QA Supervisor - Chile - World Courier de Chile Ltda.

Descripción

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today

What you will be doing

POSITION SUMMARY:

This role, as a quality representative plays a crucial role in ensuring compliance with World Courier policies and procedures at the local level. They are responsible for overseeing quality-related activities within the Clinical Trial, Commercial, and Transport divisions of the organization. They provide guidance to office, depots and divisional associates on matters of quality and compliance. Additionally, they are responsible for ensuring compliance with local regulatory requirements related to operations and may have regulatory responsibilities in front of local authorities.

TASKS AND KEY AREAS OF RESPONSIBILITY

1) Quality Management System (QMS)

a) QMS Management: Developing and maintaining a robust QMS that defines the organization's quality objectives, policies, procedures, and performance metrics. This includes to act as a first contact for the Country Manager and local team for quality related topics. And to ensure that quality aspects for CCS and Transport are adequatly represented during local and global meetings as well as local and global projects and initiatives.

Organize and support management review meetings in accordance to applicable SOP.

b) Supplier Qualification Management: Oversee the Suppliers Evaluation Program in accordance with internal guidelines, including local suppliers approval / rejection. This involves working closely with subject matter experts and the local operational team to ensure that subcontractors and suppliers meet the necessary qualifications and standards. To ensure supplier meet quality expectations through supplier audits, performance monitoring, and corrective actions when necessary.

c) Quality Agreements: To review and negotiate quality agreements and Confidentiality Disclosure Agreements (CDAs/NDAs). This includes carefully examining the terms and conditions outlined in these agreements, ensuring alignment with company policies and regulatory requirements.

d) Internal / External Audits, Inspections and certification audits: To be the main auditor contact and to communicate with relevant parties within the organization. To initiate and oversee the audit organization. Respond promptly to auditor inquiries by providing accurate information, supporting documentation, or clarification as needed. Work with

management teams to develop and follow up action plans for addressing any identified non-compliance issues and provide audit responses in due time.

e) Incident Management: Review and manage the documentation on incidents. Actively participating in investigations on non-conformities or deviations from established quality standards. Provide quality input for investigations, root cause analysis and CAPA and support corrective and preventive action initiatives to address root causes. Assisting in the creation of comprehensive reports, and diligently monitoring deviations and subsequent actions as outlined in the specific internal guidelines. Reporting to global QA and local leadership any deviations or potential problems.

Ensuring that relevant customer complaints are dealt with effectively.

f) Risk Management and Change Control: Assist in setting up and to participate in Risk Management and Change Control processes. To ensure that clients are contacted whenever required in order to communicate changes such as but not limited to expansions, depot moving process, regulatory updates clarifications, etc.

g) Pest Control and Facility Cleaning: To ensure that pest control and cleaning programs are properly implemented and documented following applicable SOPs.

h) Technical Quality Support: Overview and verify technical change controls, calibration, maintenance and qualification / validation program according to internal guidelines, supporting the local facility representative and QA manager technical compliance.

Support the review of temperature graphs as defined in applicable SOP.

i) Documentation Management: Ensuring accurate documentation of all quality-related activities such as SOPs, work instructions, test records, audit reports, etc.

This also includes to organize regular reviews of, e.g. Local Standard Operating Procedures (SOPs) and Work Instructions (WIs) with the process owner / author. To support the review of these documents to ensure that they align with established service standards as well as quality and regulatory requirements.

j) Quality Data Management: To execute all tasks using dedicated software tools such as Master Control and SharePoint (or other applicable software tools). This includes accurately inputting and timely updating data, attaching relevant documents, tracking progress, documenting actions taken, and adhering to any specific workflows or process as outlined in the standard operating procedures.

2) Quality Control

a) Quality Checks and Control: Implementing processes to monitor product or service quality throughout the entire lifecycle from design to delivery. This may involve conducting inspections and analyzing data to ensure accurancy and quality of records, to identify defects or areas for improvement.

b) Self Inspection and Quality Checks: Responsible for quality related activities related to the Self-Inspection Report as well as quality checks as defined in standard procedure.

c) Manufacturing (CSS only):

· Ensure that the batch processing and final records related to the relabeling operation are reviewed through QA spot checks and documented appropriately.

· Packaging Material: To conduct Quality checks and release for GMP-related materials for secondary repacking activities.

· Packaging / Labelling: To conduct and document quality checks for secondary repacking activities. To review the completeness of the batch packaging records and ensure all data are filled in in accordance with World Courier's Good Documentation Practices procedure.

To review and approve the repacked products to the client for client's final release and disposition.

To ensure that physical batch packaging records are retained and archived.

3) Compliance Assurance

· Ensuring compliance with relevant regulations (local law, GDP, quality regulations etc), industry standards (such as ISO and relevant GxP standards), customer requirements, and internal policies. Staying up-to-date with changes in regulations and triggering / implementing necessary QMS changes.

· Verifying adherence of World Courier employees to all Company Policies and Procedures as applicable to their role and responsibilities through effective monitoring, guidance, and support during standard process implementation.

· Ensure that World Courier License(s) as well as any other regulatory documentation is/are properly in place and updated as applicable.

4) Quality Training and Education

a) Training Program: Developing training programs to educate employees on quality standards, quality processes, and quality techniques. Ensuring that initial and continuous training programs are implemented and maintained related to Good Documentation, Good Manufacturing, Good Distribution and Good Clinical Practices (when applicable).

b) Internal Guidelines Training Management: To assign along with the local Management and maintain the local training job codes and local training matrix. To monitor training compliance and escalate non-compliance to local management.

5) Process Improvement

a) Continuous Improvement: Identifying opportunities for process improvements through data analysis and continuous evaluation of existing workflows. This may include implementing Lean Six Sigma methodologies or other improvement frameworks in collaboration with the Continuous Improvement department.

b) Customer Satisfaction: Participate in client meetings, monitoring client feedback and satisfaction levels to identify areas for improvement in services. To enhance the quality of service delivered to clients by closely collaborating with the operational team.

6) Operational Quality Support (CSS / Responsible Person only)

a) Recalls: To support recalls and mock recalls in accordance with applicable internal guidelines and client instructions.

b) Destruction: To act as witness during the destruction process for stored products, e.g. IMP/Clinical Trial Material or commercial products when required.

c) Commercial Product Handling (commercial only):

· To complete inbound quality checks and confirmation of client's disposition in approval process for 3PL.

· To review and authorize the change of product status following client instructions and within the scope of applicable Internal Guidelines.

· Confirm client's disposition of returned, rejected, recalled or falsified products (if applicable).

· Confirm client's disposition of approving any returns to saleable stock (if applicable).

7) Others:

a) Keeping appropriate records of any delegated duties and execute tasks and responsibilities as per delegation plan or assigned to the QA support team.

b) Any other quality responsibilities assigned by Regional/Global Quality Management.

c) International support on QA related matters for the local QA network.

What your background should look like

EDUCATIONAL REQUIREMENTS:

The employee should hold a minimum of a diploma or of a bachelor's degree in a relevant field such as pharmacy, chemistry, biochemistry, pharmaceutical sciences, logistics or engineering. A degree in quality management or a related discipline might also be acceptable.

KEY EXPERIENCE AND DELIVERABLES EXPECTED

· Supervisor, basic experience in quality at least 2 to 5 years

In the role of the quality Supervisor, the employee should have the knowledge and experience to make all routine decision independently. Supervision and support is required by the line manager for new and more complex situtions. Approval of key documents will be done under supervision of the line manager or by the line manager.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

a. Good verbal and written interpersonal and communication skills in English and local language.

b. Ability to express oneself clearly in conversations, interactions and business writing with others.

c. Develop and maintain good relationships with associates at all levels within the company and with external parties (e.g. clients, vendors etc.).

d. Good Awareness of Customer Needs.

e. Intermediate Awareness of business requirements of the organization.

f. Having a high sense of integrity, transparency and accountability in all work tasks and interactions with others.

g. Detailed, well-organized and able to multi-task and manage multiple projects at the same time, prioritizing required actions accordingly to meet required deadlines.

h. Strong drive to remain focused, self-motivated and committed to completing or achieving tasks.

i. Excellent skills in Microsoft Office (Excel, Word and PowerPoint).

j. Able to work independently and with a team when required. OR Able to work independently and lead a team when required.

REPORTS DIRECTLY TO:

·

· Dotted line to Country Manager

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.

To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Schedule

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today

What you will be doing

POSITION SUMMARY:

This role, as a quality representative plays a crucial role in ensuring compliance with World Courier policies and procedures at the local level. They are responsible for overseeing quality-related activities within the Clinical Trial, Commercial, and Transport divisions of the organization. They provide guidance to office, depots and divisional associates on matters of quality and compliance. Additionally, they are responsible for ensuring compliance with local regulatory requirements related to operations and may have regulatory responsibilities in front of local authorities.

TASKS AND KEY AREAS OF RESPONSIBILITY

1) Quality Management System (QMS)

a) QMS Management: Developing and maintaining a robust QMS that defines the organization's quality objectives, policies, procedures, and performance metrics. This includes to act as a first contact for the Country Manager and local team for quality related topics. And to ensure that quality aspects for CCS and Transport are adequatly represented during local and global meetings as well as local and global projects and initiatives.

Organize and support management review meetings in accordance to applicable SOP.

b) Supplier Qualification Management: Oversee the Suppliers Evaluation Program in accordance with internal guidelines, including local suppliers approval / rejection. This involves working closely with subject matter experts and the local operational team to ensure that subcontractors and suppliers meet the necessary qualifications and standards. To ensure supplier meet quality expectations through supplier audits, performance monitoring, and corrective actions when necessary.

c) Quality Agreements: To review and negotiate quality agreements and Confidentiality Disclosure Agreements (CDAs/NDAs). This includes carefully examining the terms and conditions outlined in these agreements, ensuring alignment with company policies and regulatory requirements.

d) Internal / External Audits, Inspections and certification audits: To be the main auditor contact and to communicate with relevant parties within the organization. To initiate and oversee the audit organization. Respond promptly to auditor inquiries by providing accurate information, supporting documentation, or clarification as needed. Work with

management teams to develop and follow up action plans for addressing any identified non-compliance issues and provide audit responses in due time.

e) Incident Management: Review and manage the documentation on incidents. Actively participating in investigations on non-conformities or deviations from established quality standards. Provide quality input for investigations, root cause analysis and CAPA and support corrective and preventive action initiatives to address root causes. Assisting in the creation of comprehensive reports, and diligently monitoring deviations and subsequent actions as outlined in the specific internal guidelines. Reporting to global QA and local leadership any deviations or potential problems.

Ensuring that relevant customer complaints are dealt with effectively.

f) Risk Management and Change Control: Assist in setting up and to participate in Risk Management and Change Control processes. To ensure that clients are contacted whenever required in order to communicate changes such as but not limited to expansions, depot moving process, regulatory updates clarifications, etc.

g) Pest Control and Facility Cleaning: To ensure that pest control and cleaning programs are properly implemented and documented following applicable SOPs.

h) Technical Quality Support: Overview and verify technical change controls, calibration, maintenance and qualification / validation program according to internal guidelines, supporting the local facility representative and QA manager technical compliance.

Support the review of temperature graphs as defined in applicable SOP.

i) Documentation Management: Ensuring accurate documentation of all quality-related activities such as SOPs, work instructions, test records, audit reports, etc.

This also includes to organize regular reviews of, e.g. Local Standard Operating Procedures (SOPs) and Work Instructions (WIs) with the process owner / author. To support the review of these documents to ensure that they align with established service standards as well as quality and regulatory requirements.

j) Quality Data Management: To execute all tasks using dedicated software tools such as Master Control and SharePoint (or other applicable software tools). This includes accurately inputting and timely updating data, attaching relevant documents, tracking progress, documenting actions taken, and adhering to any specific workflows or process as outlined in the standard operating procedures.

2) Quality Control

a) Quality Checks and Control: Implementing processes to monitor product or service quality throughout the entire lifecycle from design to delivery. This may involve conducting inspections and analyzing data to ensure accurancy and quality of records, to identify defects or areas for improvement.

b) Self Inspection and Quality Checks: Responsible for quality related activities related to the Self-Inspection Report as well as quality checks as defined in standard procedure.

c) Manufacturing (CSS only):

· Ensure that the batch processing and final records related to the relabeling operation are reviewed through QA spot checks and documented appropriately.

· Packaging Material: To conduct Quality checks and release for GMP-related materials for secondary repacking activities.

· Packaging / Labelling: To conduct and document quality checks for secondary repacking activities. To review the completeness of the batch packaging records and ensure all data are filled in in accordance with World Courier's Good Documentation Practices procedure.

To review and approve the repacked products to the client for client's final release and disposition.

To ensure that physical batch packaging records are retained and archived.

3) Compliance Assurance

· Ensuring compliance with relevant regulations (local law, GDP, quality regulations etc), industry standards (such as ISO and relevant GxP standards), customer requirements, and internal policies. Staying up-to-date with changes in regulations and triggering / implementing necessary QMS changes.

· Verifying adherence of World Courier employees to all Company Policies and Procedures as applicable to their role and responsibilities through effective monitoring, guidance, and support during standard process implementation.

· Ensure that World Courier License(s) as well as any other regulatory documentation is/are properly in place and updated as applicable.

4) Quality Training and Education

a) Training Program: Developing training programs to educate employees on quality standards, quality processes, and quality techniques. Ensuring that initial and continuous training programs are implemented and maintained related to Good Documentation, Good Manufacturing, Good Distribution and Good Clinical Practices (when applicable).

b) Internal Guidelines Training Management: To assign along with the local Management and maintain the local training job codes and local training matrix. To monitor training compliance and escalate non-compliance to local management.

5) Process Improvement

a) Continuous Improvement: Identifying opportunities for process improvements through data analysis and continuous evaluation of existing workflows. This may include implementing Lean Six Sigma methodologies or other improvement frameworks in collaboration with the Continuous Improvement department.

b) Customer Satisfaction: Participate in client meetings, monitoring client feedback and satisfaction levels to identify areas for improvement in services. To enhance the quality of service delivered to clients by closely collaborating with the operational team.

6) Operational Quality Support (CSS / Responsible Person only)

a) Recalls: To support recalls and mock recalls in accordance with applicable internal guidelines and client instructions.

b) Destruction: To act as witness during the destruction process for stored products, e.g. IMP/Clinical Trial Material or commercial products when required.

c) Commercial Product Handling (commercial only):

· To complete inbound quality checks and confirmation of client's disposition in approval process for 3PL.

· To review and authorize the change of product status following client instructions and within the scope of applicable Internal Guidelines.

· Confirm client's disposition of returned, rejected, recalled or falsified products (if applicable).

· Confirm client's disposition of approving any returns to saleable stock (if applicable).

7) Others:

a) Keeping appropriate records of any delegated duties and execute tasks and responsibilities as per delegation plan or assigned to the QA support team.

b) Any other quality responsibilities assigned by Regional/Global Quality Management.

c) International support on QA related matters for the local QA network.

What your background should look like

EDUCATIONAL REQUIREMENTS:

The employee should hold a minimum of a diploma or of a bachelor's degree in a relevant field such as pharmacy, chemistry, biochemistry, pharmaceutical sciences, logistics or engineering. A degree in quality management or a related discipline might also be acceptable.

KEY EXPERIENCE AND DELIVERABLES EXPECTED

· Supervisor, basic experience in quality at least 2 to 5 years

In the role of the quality Supervisor, the employee should have the knowledge and experience to make all routine decision independently. Supervision and support is required by the line manager for new and more complex situtions. Approval of key documents will be done under supervision of the line manager or by the line manager.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

· Supervisor (People Manager)

a. Good verbal and written interpersonal and communication skills in English and local language.

b. Ability to express oneself clearly in conversations, interactions and business writing with others.

c. Develop and maintain good relationships with associates at all levels within the company and with external parties (e.g. clients, vendors etc.).

d. Good Awareness of Customer Needs.

e. Intermediate Awareness of business requirements of the organization.

f. Having a high sense of integrity, transparency and accountability in all work tasks and interactions with others.

g. Detailed, well-organized and able to multi-task and manage multiple projects at the same time, prioritizing required actions accordingly to meet required deadlines.

h. Strong drive to remain focused, self-motivated and committed to completing or achieving tasks.

i. Excellent skills in Microsoft Office (Excel, Word and PowerPoint).

j. Able to work independently and with a team when required. OR Able to work independently and lead a team when required.

REPORTS DIRECTLY TO:

·

· Dotted line to Country Manager

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.

To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

For details, visit amerisourcebergen

Schedule

Affiliated Companies

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

About Us

Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them.

We're a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.