POSITION SUMMARY

Establish and maintain an appropriate and sustainable Product Quality System and Quality Culture within Pfizer and any contractor related to Gold Distributions Practices (GDP) activities.
Ensures compliance with Pfizer and Regulatory authority expectations and protection of Pfizer patients/customers from any product quality risk.

EDUCATION AND EXPERIENCE

• Bachelor degree in science/ pharmacy
• Experience in Quality Assurance role
• Background in handling product complaints
• Experience in completing / reviewing Annual Product Quality Reviews (APQR)

TECHNICAL SKILLS REQUIREMENTS

Technical skills required and/or preferred, as applicable.

• Strong analytical and problem-solving skills
• Ability to work independently and as part of a team
• Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
• Ability to adapt to changing priorities and manage multiple tasks simultaneously
• Excellent technical writing, communication, and presentation skills
• Experience in preparing and participating in audits and inspections

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control

Maintenance of the compliance to the Regulatory Authority/ Board of Health (BoH) Regulations

• Support the product quality and compliance of authorized activities, to ensure Board of Health (BoH) expectations are met.
• Support Responsible Pharmacist (RP) 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

Governance & Internal Organization
Together with Sr Manager/ Manager monitor Key Indicators Performance (KPIs), highlight any significant trends and identify improvement opportunities.
Assess new local regulatory requirements.
Responsible for the timely implementation of all applicable Global Standard Operating Procedures (GSOPs).

Development and Maintenance of consistent Quality culture:

• Support training program implementation for all quality related tasks of the employees involved in the distribution of medicinal products is completed.
• Maintain competence in Good Distribution Practices (GDP) through regular training.

Inspection and Internal Audit:

• Support preparation and coordination of the GDP / Marketing Authorization Holder (MAH) related regulatory inspections or Pfizer internal/RQA audits.
• Work with Sr Manager in Corrective and Preventive Actions (CAPA) Plan implementation and its completion within agreed timelines.

Commitment Tracking:

• Manage commitments.

Change Management:

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

Product quality assurance & operations

Notification to Management (NtM):

• Notify SOQ Sr Manager/Leaders of significant deviations and any issue impacting marketed product in compliance with NtM GSOP.
• Attend Pfizer Country Office (PCO) Quality Review Team meetings to ensure cross-functional input.

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).

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 with effectively.

Market Returns:

• Support the evaluation of the returned goods.

Services or contractor management:

• Support the oversee of Pfizer quality operations at contractors.
• Ensure quality agreements are maintained and updated.
• Coordinate, support and participate in RQA Audits to contractors and LSPs. Track CAPA Plan.
• Notify SOQ Sr Manager/Leaders of significant concerns or repeated deviations occurred with contractors and all issues potentially affecting marketed product.

Perform Annual Product Quality Reviews (APQR)

• Prepare local annual product quality review reports (APQR) based on annual PQR Product schedule.
• Provides SOQ PQR report to Regulatory Affairs colleague for review and Responsible Pharmacist for review and approval.
• Manages timelines and review comments of all APQRs, post review.