- Experience Needed:
3 to 7 years
- Career Level:
- Job Type:
- Full Time
About the Job
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
- 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.
- 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.
- 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
- 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.
- 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 auditor
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.
- 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.
- Notifies the 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).
3 to 7 years
Years of experience: 3-7 years in the Pharmaceutical or related regulated industry
- 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
- Change Agile
- Planning & Organizing skills
- Able to Make decisions within guidelines and policies
- To use new ideas and knowledge with increasing frequency, Begins to explore and apply ingenuity to experimentation .
- Able to work in ambiguous situations as part of a Work Team
- Applies technical skills to achieve assigned tasks
- Has effective communication, writing and negotiation skills
- Able to align with global strategies
- Efficiently represents Quality Compliance positions
About this Company
Pfizer, the world’s largest pharmaceuticals firm and one of the oldest in America, has a long history in Egypt. It entered the country over half a century ago, in 1961. Since then it has grown to become Egypt’s seventh-largest drug provider, employing more than 600 people...
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