Job Description

• Pfizer Senior Officer Quality (SOQ)

Job Focus

The Key role of Pfizer SOQ 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. SOQ is the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the DC and for interacting with the relevant stakeholders and local regulatory authorities on such issues. Coordinates and monitors the product quality and compliance activities at the DC to ensure that current regulatory expectations are met and facilitates internal and regulatory GDP inspections.

Job Summary

• Main Areas of Responsibility / Accountabilities

1.

Maintenance of Compliance to Local BOH Regulations:

• Main focus 1: Coordinate the product quality and compliance activities at the DC, to ensure current BOH expectations are met
• Main focus 2: 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 and Internal Organization:

• Main focus 1: Support timely implementation of all applicable Product Quality activities
• Main focus 2: Ensure that all relevant DC colleagues are appropriately trained in the Product Quality SOPs
• Main focus 3: Assess new quality system and local regulatory requirements to enhance and align local systems and processes when required
• Main focus 4: Conduct and document periodic assessments to determine if a revision, retirements, administrative change or no change is required for the Product Quality SOPs (issued by SOQ) within the DC

3. Quality Metrics

• Main focus 1: Collect data and report quality metrics of DC and contractors to allow quality performance assessment
• Main focus 2: Together with the SOQ manager/ Sr manager, assess quality performance to identify trends and improvement opportunities
• Main focus 3: Participate in the DC/Contractors quality management reviews and follows-up for the recommended actions, when required

4. Training

• Main focus 1: Support the implementation of all elements of SOQ Training systems in DC, including implementation and annual training on GDP/GMP to applicable DC colleagues
• Main focus 2: Ensure that all assigned Pfizer trainings (PLA) are completed in timely manner

5. Commitment Tracking

• Main focus 1: Use and maintain tracking tools to track any GXP commitments raised by SOQ or under SOQ Oversight
• Main focus 2: For any commitment opened, ensure that due dates are based on risk, complexity and urgency, and that timeframes given are realistic, to meet the stated requirements

6. Change Controls

• Main focus 1: Handle any planned, permanent and temporary changes of GMP/GDP related activities and systems in the DC
• Main focus 2: Participate in the change committee as appropriate and ensure the required approvals
• Main focus 3: Ensure change actions completion as per the agreed timelines

7.

Inspection and Internal Audit:

• Main focus 1: Participate in preparation and coordination of external and Pfizer internal inspections and audits
• Main focus 2: Support the development of CAPA plans and follow-up to the timely closure in coordination with other relevant functions
• Main focus 3: 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

8.

Quality Risk Management:

• Main focus 1: Perform Risk assessments for any identified risks and ensure compliance with Quality risk management process

9. Notification to Management (NTM)

• Main focus 1: Inform SOQ manager of any significant deviations and complaints, that could lead into an NTM
• Main focus 2: Ensure notification is done within the appropriate timeline and process

10. Deviation Management

• Main focus 1: Perform if needed, investigation of product quality incidents that occur within the responsibility of SOQ DC in Cooperation with the relevant internal/external functions
• Main focus 2: Track the preventive and corrective actions until completion within the set due dates

11. Local Repackaging/Relabeling Operations

• Main focus 1: Ensure that contractors have been assessed and approved before performing any relabeling/repackaging activity
• Main focus 2: Depending on the local model/ Structure if needed, obtains regulatory approval of the repackaging/relabeling activity
• Main focus 3: Complete the required documentation and obtain the necessary approvals from Pfizer regulatory functions and manufacturing sites
• Main focus 4: Oversee the process of repackaging/Relabeling and review operations related documents

12.

Local Product Disposition:

• Main focus 1: Manages the sampling of imported finished products to support the local product disposition process
• Main focus 2: Manages the IFP samples room
• Main focus 3: Ensure the application of the disposition decision of the quality in the DC
• Main focus 4: Manages the IFP archiving room and activities

13. Returns

• Main focus 1: Assess the returned goods and provide a disposition decision

14.

Quality Alert Notice:

• Main focus 1: Receive and manage Quarantine alert notice (QAN) issued by Pfizer manufacturing site, Contractor manufacturing site or distribution center
• Main focus 2: Ensure status of impacted batches at logistics center/LSP/Contract vendor is changed to blocked/Hold
• Main focus 3: Provide the required responses to QAN issuing site on timely manner
• Main focus 4: Ensure status of impacted batches is aligned with the final disposition decided by QAN issuing site

15. Market Action (Special Situation)

• Main focus 1: Attend, as needed, Area quality review teams (AQRT) meetings, as DC representative, to provide the local perspective on the issue at hand
• Main focus 2: Support SOQ manager to provide the local perspective on the issue and draft AQRT executive summary for issues originating under the responsibility of the DC
• Main focus 3: 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

16.

DC External Service Providers Management and Oversight:

• Main focus 1: Ensure quality oversight of Pfizer DC external service providers
• Main focus 2: Participate as needed in external service providers visits/audits
• Main focus 3: Review, negotiate, and track, according to the SOQ manager/ SOQ lead instructions and maintain up to date quality agreements of GMP/GDP contractors

17. Quality Agreements

• Main focus 1: Review, negotiate and maintain up to date quality agreements of GMP/GDP contractors according to SOQ manager / SOQ lead instructions

18. Post-Release Activities

• Main focus 1: Imported finished products (IFP) samples management
• Main focus 2: Management of destruction of samples used for quality checks
• Main focus 3: IFP batch record archiving management
• Main focus 4: Application of disposition labels
• Main focus 5: Batch release Second person verification
• Main focus 6: Management of customers requests of documents (IFP COA and COC)

19. Archival Management

• Main focus 1: Archiving management of IFP batch record, relabeling/Repackaging dossiers and all SOQ DC documents (quality agreements, training attendances, logbooks, returns etc…)

20. Backup

• Main focus 1: Ensure SOQ officer backup

Key Performance Indicators (KPI)

• Works according to relevant SOP / WI

Qualifications

Level of Education:

• Master's degree in Quality management

Experience:

• 2-5 years in the pharmaceutical or related regulated industry

Languages:

• Fluent in Arabic, French and English

Computer Skills:

• Excel, PowerPoint, Word

Competencies – Personal Capabilities

• Good knowledge in quality principles, concepts and basic technical skills
• Able to participate in cross-functional team
• An appropriate education in quality topics

Work Location

Assi