Supply Chain Quality Operations Officer At Pfizer Egypt
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
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
Basic level in English
Soft skills/ Management & Leadership Skills
Self-motivated, Business acumen
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