وظائف شركة فايزر للادوية Pfizer Egypt
Supply Chain & Market Operations Quality Officer
Job Responsibilities:
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 SCMOQ Manager/ Sr Manager, assess quality performance to
identify trends and improvement opportunities.
Participates in the PCO/Contractor’s quality management reviews and follows-up
for the recommended actions.
Uses and maintains tracking tools to track any GxP commitments raised by SCMOQ
or under SCMOQ 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.
Informs SCMOQ 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.
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.
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.
Support SCMOQ manager to provide the local perspective on the issue and draft
AQRT Executive Summary for issues originating under the responsibility of the
PCO.
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 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
