Job Description

Organization overview The key role of Pfizer SCQ Officer is to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture within Pfizer and any contractor related to GMP/GDP activities, so that compliance with Pfizer and Regulatory authority expectations and protection of Pfizer patients/customers from any product quality risk are ensured. SCQ is the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the PCO and for interacting with the relevant stakeholders and local regulatory authorities on such issues. SCQ Officer Coordinates and monitors the product quality and compliance activities at the PCO to ensure that current regulatory expectations are met and facilitates internal and regulatory GDP inspections. Role description and Main responsibilities 1.Maintenance of the compliance to the local BOH regulations Coordinate the product quality and compliance activities at the PCO/DC, to ensure current BOH expectations are met. Act as the Qualified / Responsible Person to local authorities or support Qualified Person activities for all Pfizer Product Quality Compliance issues in the market. 2.Governance & internal organization Support timely implementation of all applicable Product Quality SOPs (issued by SCQ) within the PCO/DC. Ensure that all relevant PCO/DC colleagues are appropriately trained in the Product Quality SOPs. Assess new quality system and local regulatory requirements to enhance and align local systems and processes when required. Conduct and document periodic assessments to determine if a revision, retirement, administrative change or no change is required for the Product Quality SOPs (issued by SCQ) within the PCO/DC. Quality Metrics Collect data and reports quality metrics of PCO, DC and contractors to allow quality performance assessment. Together with the SCQ Manager/ Sr Manager, assess quality performance to identify trends and improvement opportunities. Participate in the PCO, DC and Contractors quality management reviews and follows-up for the recommended actions, when required Training Support the implementation of all elements of SCQ Training systems in PCO and DC, including implementation and annual training on GDP/GMP to applicable PCO and DC colleagues. Ensure that all assigned Pfizer trainings are completed in timely manner Commitment Tracking Use and maintain tracking tools to track any GxP commitments raised by SCQ or under SCQ oversight. For any commitment opened, ensure that due dates are based on risk, complexity, and urgency, and that the timeframes given are realistic, to meet the stated requirements. Change Controls Handle any planned, permanent and temporary changes of GMP/ GDP related activities and systems in the PCO and DC. Participates in the changes committee as appropriate and ensures the required approvals. Ensures change actions completion as per the agreed timelines. Inspection and Internal Audit Participate in preparation and coordination of external and Pfizer internal inspections and audits. support the development of CAPA plans and follow-up to the timely closure in coordination with other relevant functions. Internal self-inspection process management Support / Ensure the timely implementation of the self-inspection plan as per the assigned tasks as auditee and / or auditor.

3.Product quality assurance & operations

Manage the following systems: Notification to Management Deviations Product Complaint Handling Local Product Disposition & Temperature excursion Local Repackaging/Relabeling operations Returns Quarantine Alert Notices (special situation) Market Action (special situation)

4. LSP / contractor management & oversight Participate as needed in contactors visits/ audits. Review, negotiate and track, according to the Manager/ Sr Manager instructions and maintain up to date Quality Agreements of GMP/GDP contractors. Quality agreements Review, negotiate and maintain up to date Quality Agreements of GMP/GDP contractors according to the Manager/ Sr Manager instructions. Qualifications/ Skills

Years of experience: 0-5 years in the Pharmaceutical or related regulated industry Technical skills Has an appropriate education in science or quality topics; Bachelor's degree, pharmacist, Engineer. Has basic knowledge of the Quality principles, concepts of Quality and basic technical skills Has basic knowledge about Quality Systems (Change Control, deviations, complaint management, documentation management, audits, inspections, etc.) Able to Participate effectively in cross-functional team Analytical skills Good level in English

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

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