Supply Chain Quality Officer

7 days ago

Mansoura, Egypt Pfizer Full time

1.Maintenance of the compliance to the local BOH regulations

2.Quality Management systems
- Supports timely implementation of all applicable Product Quality SOPs within the PCO.
- Conducts and documents periodic assessments for the Product Quality SOPs 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.
- Uses and maintains tracking tools to track any GxP commitments raised by SCQ or under SCQ oversight.
- Handles any planned, permanent and temporary changes of GMP/ GDP related activities and systems in the PCO. Ensures change actions completion as per the agreed timelines.
- 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.
- Support / Ensure the timely implementation of the self-inspection plan as per the assigned tasks as auditee and / or auditor.
- 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 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.
- Manage the intake 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).
- 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).
- 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.
- 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.
- Assess the returned goods and provide a disposition decision
- Receives and manages Quarantine Alert Notices (QAN) issued by Pfizer manufacturing site, Contractor manufacturing site or distribution center.
- Ensure status of impacted batches at logistics center/LSP/contract vendor is changed to Blocked/Hold
- Provide the required responses to QAN issuing site on timely manner.
- Ensure status of impacted batches is aligned with the final disposition decided by QAN issuing site.
- Support SCQ manager to provide the local perspective on the issue and draft AQRT Executive Summary for issues originating under the responsibility of the PCO.
- 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
- Participates as needed in contactors visits/ audits.
- Reviews, negotiates and tracks, according to the Manager/ Sr Manager instructions and maintain up to date Quality Agreements of GMP/GDP contractors.
- Review, negotiate and maintain up to date Quality Agreements of GMP/GDP contractors according to the Manager/ Sr Manager instructions.

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

Success criteria
- 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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each

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