Organization overview
The key role of Pfizer SCMOQ 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. SCMOQ 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.

Role description and Main responsibilities

Maintenance of the compliance to the local BOH regulations
Coordinate the product quality and compliance activities at the PCOs, 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.

Governance & internal organization

Support timely implementation of all applicable Product Quality SOPs (issued by SCMOQ) within the PCO. Ensure that all relevant PCO 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 SCMOQ) within the PCO.

Quality Metrics

Collect data and report quality metrics of PCO and contractors to allow quality performance assessment. Together with the SCMOQ Manager/ Sr Manager, assess quality performance to identify trends and improvement opportunities. Participate in the PCO/Contractors quality management reviews and follows-up for the recommended actions, when required.

Training

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

Commitment Tracking

Use and maintain tracking tools to track any GxP commitments raised by SCMOQ or under SCMOQ 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. Participate in the changes committee as appropriate and ensures the required approvals. Ensure 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.

Product quality assurance & operations

Ensure efficient management and appropriate Quality Oversight of the following systems:
Notification to Management Deviations/Investigations Products Complaints Local Product Disposition & Temperature excursion Local Repackaging/Relabeling operations Returns Market Action (special situation)

LSP / contractor management & oversight

Quality agreements Management
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 Basic level in English

Soft skills/ Management & Leadership Skills

Self-motivated, Business acumen Act Assertively Grows Self Accountable Change Agile Self-Awareness Planning & Organizing skills Able to Make decisions within guidelines and policies
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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