القائمة الرئيسية

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Supply Chain Quality Officer At Pfizer Egypt

 Supply Chain Quality Officer At Pfizer Egypt



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 Pizer 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. 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


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.

2. Governance & internal organization 


Supports timely implementation of all applicable Product Quality SOPs (issued by SCQ) within the PCO.

Ensures that all relevant PCO colleagues are appropriately trained in the Product Quality SOPs.

Assess new quality system and local regulatory requirements to enhances and align local systems and processes when required.

Conducts and documents 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.

Quality Metrics


Collects data and reports quality metrics of PCO and contractors to allow quality performance assessment.

Together with the SCQ Manager/ Sr Manager, assess quality performance to identify trends and improvement opportunities.

Participates in the PCO/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, including implementation and annual training on GDP/GMP to applicable PCO colleagues.

Ensure that all assigned Pfizer trainings (P2L for example) are completed in timely manner

Commitment Tracking


Uses and maintains 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


Handles any planned, permanent and temporary changes of GMP/ GDP related activities and systems in the PCO.

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.

supports 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 


Notification to Management


Informs SCQ manager of any significant deviations and complaints, that could lead into a NTM.

Ensure notification is done within the appropriate timeline and process.

Deviation Management


Perform, if needed, investigation of product quality incidents that occur within the responsibility of Pfizer country office in cooperation with the relevant internal/external functions.

Track the preventive and corrective actions until completion within the set due dates.

Product Complaint Handling


Manage the intake and triage of complaints from the markets under PCO responsibility, classify the product complaint, and forwards them to the appropriate investigating PGS/Contractor manufacturing site via the global complaints management system (QTS-CITI).

Develops and issues responses to complainants in a timely manner

Tracks complaint responses.

Notifiesthe Management when needed.

Local Product Disposition & Temperature excursion


Review all documents and records relevant to the imported products and perform the necessary activities to provide a disposition decision to the products to the market sale in compliance with local regulatory requirements and Pfizer procedures.

Communicate the disposition decision with internal and external stakeholders.

Document any temperature excursion and coordinate with manufacturing site for assessment and via the global Quality Tracking System (QTS).

Local Repackaging/Relabeling operations


Ensures that contractors have been assessed and approved before performing any relabeling/repackaging activity.

Depending on the local model/ structure, if needed, obtains Regulatory approval of the repackaging/relabeling activity.

Completes the required documentation and obtains the necessary approvals from Pfizer Regulatory functions and manufacturing sites.

Oversees the process of repackaging/relabeling and reviews operation related documents.

Releases the repackaged/relabeled products according to the local decision matrix or according to the Manager/ Sr Manager instructions.

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