Supply Chain Quality Officer (Egypt-Sudan)

Pfizer - Cairo

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Experience Needed:
3 to 7 years
Career Level:
Experienced (Non-Manager)
Job Type:
Full Time
Salary:
Confidential
Vacancies:
1 open position
About the Job

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 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).

Etc,….                                                                                        

Job Requirements

Qualifications/ Skills                                                                                                                 

Years of experience: 3-7 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
About this Company

Pfizer, the world’s largest pharmaceuticals firm and one of the oldest in America, has a long history in Egypt. It entered the country over half a century ago, in 1961. Since then it has grown to become Egypt’s seventh-largest drug provider, employing more than 600 people... (More)

See all Careers and Jobs at Pfizer
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