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.