Supply Chain Quality Pharmacist at Pfizer

1.Maintenance of the compliance to the local Health regulations

• Coordinate the product quality and compliance activities at the Pfizer Country Office, to ensure current regulatory expectations are met.
• Support Responsible Pharmacist activities for all Pfizer Product Quality Compliance issues in the market.
   

2. Governance & internal organization

• Supports timely implementation of all applicable Product Quality SOPs
• Ensures that all relevant 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
   

2.1 Quality Metrics

• Collects data and reports quality metrics of Pfizer Country Office (PCO) and contractors to allow quality performance assessment.
• Together with the SCQ Manager/ Lead, 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.
   

2.2 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 are completed in timely manner
   

2.3 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.

2.4 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.
   

2.5 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.
   

3 Product quality assurance & operations
3.1 Notification to Management

• Informs SCQ Lead of any significant deviations and complaints, that could lead into a NTM.
• Ensure notification is done within the appropriate timeline and process.
   

3.2 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.

3.3 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 Release & 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).

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

LSP / contractor management & oversight

• 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.

Quality agreements

• Review, negotiate and maintain up to date Quality Agreements of GMP/GDP contractors according to the Manager/ Sr Manager instructions.
   

Product Quality Review

• Pharmacist registered with the South African Pharmacy Council

Qualifications/ Skills

• Masters degree is an advantage
• Years of experience: 0-5 years in the Pharmaceutical or related regulated industry

Technical skillsSoft skills/ Management & Leadership SkillsSuccess criteriaPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

• Perform PQR's timeously as per the approved annual schedule
   
• 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
   
• Self-motivated, Business acumen
• Act Assertively
• Grows Self
• Accountable
• Change Agile
• Self-Awareness
• 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