وظائف
شركة فايزر للادوية Pfizer Egypt
Supply Chain Quality Officer
Role description and Main responsibilities
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.
Quality Metrics
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.
Training
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
Commitment Tracking
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.
Change Controls
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 auditee and / or 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.
Deviation Management
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).
Local Repackaging/Relabeling operations
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.
Completes the required documentation and obtains the necessary approvals from
Pfizer Regulatory functions and manufacturing sites.
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.
Returns
Assess the returned goods and provide a disposition decision
Quarantine Alert Notices (special situation)
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.
Market Action (special situation)
Attend, as needed, Area Quality Review Teams (AQRT) meetings, as PCO
representative, to provide the local perspective on the issue at
hand.
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
Qualifications/ Skills
Years of experience: 5-7 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
#LI-PFE
