Job Description

Maintenance of the compliance to the BoH Regulations

• Coordinate the product quality and compliance authorized activities at the PCOs, to ensure current BoH expectations are met
• Ensure robust procedures are in place to manage any actual or potential falsified medicinal product in the supply chain.
• Supports the Responsible Person activities for all Pfizer Product Quality Compliance issues in the market
• Ensure robust procedures are in place to manage any actual or potential falsified medicinal product in the supply chain.
• Ensure Drug Shortage reporting as per local regulatory requirements.
• Together with SOQ RP & cluster lead monitor Key Indicators Performance (KPIs), highlight any significant trends and identify improvement opportunities.
• Responsible for the timely implementation of all applicable GSOPs.
• Ensures that all relevant PCO colleagues are appropriately trained in the Product Quality SOPs under responsibility
• Assess new quality system and local regulatory requirements to enhance and align local systems and processes when required.

Notification to Management (NtM):

• Notify SOQ RP & Cluster lead of significant deviations and any issue impacting marketed product in compliance with NtM GSOP.
• Support the local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions

Market Actions:

• Support Area Quality Review Teams (AQRT) meetings, as PCO representative to provide the local perspective.
• Ensure the implementation of the local actions identified during AQRT meetings e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions (CAPAs).

Training

• Support the implementation of all elements of SOQ Training systems in PCO, including implementation and annual training on GDP/GMP to applicable PCO colleagues
• Ensure that all assigned Pfizer Trainings on (PLA for example) are completed in timely manner.

CAPA Management:

• Tracking any GxP commitments raised by SOQ or under SOQ oversight.
• Manage commitments

Quality Metrics and Management review

• Monitor KPIs, analyze collected metrics, evaluate and highlight any significant trends and identify actions. Ensure metrics are tracked in the global system.

Change Management:

• Manage planned, permanent and temporary changes of GxP related activities

Deviation and CAPA Management & Oversight:

• Perform the investigation of deviations occurred within the responsibility of the country.
• Track CAPAs until completion.

Product Complaint Handling:

• Ensure that product quality complaints are dealt effectively.

Local Product Disposition:

• Support the local release of incoming finished products is performed in compliance with GDP regulations and Pfizer procedures prior to the distribution for sale in the country.

Customer Screening

• Ensure process is followed as per quality standards.

Supplier Qualification

• Ensure process is followed as per quality standards.

Quarantine Alert Notice (QAN)

• Receive and manage QANs.

Vendor Management

• Ensure compliance of all GMP/GDP vendors to Pfizer Requirement
• Oversea Pfizer quality operations at vendors/contractors.
• Maintaining Vendors and Supply channel qualification Status on Supplier management system
• Coordinate, support and participate in RQA audits
• Ensure timely implementation of CAPA Plans.
• Notify SOQ Leader of significant concerns or repeated deviations occurred with contractors and all issues potentially affecting marketed product.
• Ensure regular quality management review for continuous improvement.

Quality Risk Management

• Ensure quality Risk management is applied to relevant quality systems and processes.

Management of Quality Agreements:

• Support creation and maintenance of Quality Agreements with all GMP/GDP distributors involved in repackaging, storage and distribution activities.

Work Location Assignment: On Premise

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. 

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

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Quality Assurance and Control