‎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
* 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

Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
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