Manager Quality Assurance at Pfizer

Pfizer is hiring Manager QA 10-02-2023

 Manager Quality Assurance

Pfizer  Karachi Division, Sindh, Pakistan (On-site)

Full-time · Mid-Senior level

Qualifications

Must-Have

• Master's Degree/PharmD
• 5+ years experience.
• Working knowledge of current Good Manufacturing Practices {cGMP} and Data Integrity for a pharmaceutical industry
• Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced
• Proven ability to engage, develop and lead colleagues in a dynamic and changing work environment.
• Clear understanding of Human Resource Management (appointment/termination of colleagues, performance management, leave management, remuneration review)
• Clear understanding of EH&S Compliance (incident management, rehabilitation, environmental controls)
• Strong collaboration, relationship management, and interpersonal skills
• Strong people management experience
• Excellent written and oral communication skills
• Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent

Nice-to-Have

• Certified Lead Auditor
• Certified Six Sigma Green Belt

How You Will Achieve It

• Lead, direct and manage Quality Assurance Team.
• Manage Supply Chain Market Quality Operations activities for PCO.
• Ensure procedures are developed, maintained in accordance with Corporate and regulatory requirements as they relate to GMP and GLP.
• Ensure Batch Document Review for the release of the product.
• Ensure release of all locally manufactured/imported/third party manufactured products for supply is undertaken in accordance with the marketing authorization and by authorized persons.
• Utilizing the principles of Right First Time and Risk Management coordinate and manage deviations (QAR) in accordance with Pfizer Quality Standards (PQS) such that the causes of deviation are investigated and appropriate measures taken to prevent re-occurrence.
• Authorized person to reject the product on the basis of investigation as per PQS.
• Develop and maintain the effective document control program through PDOCS.
• To ensure on time issuance of manufacturing documents for the manufacturing and packaging of products.
• Develop and maintain the site product complaint system such that the causes of quality defects are investigated, and appropriate measures taken in respect of the defective products and to prevent re-occurrence. Management of CITI.
• Lead the training program at the site.
• To ensure proper handling of market returns as per defined procedure.
• Arrange daily In-process Checks of Manufacturing and Packaging areas by managing In-process Control Inspectors. Eliminate and resolve the Production related issues.
• To ensure secure and compliant storage of products reference samples as per defined storage conditions.
• To ensure safe and secure storage of batch history documents as per record retention policy.
• Visit Manufacturing and Packaging areas (Facility Walkthrough) on regular basis for the compliance of cGMP and Safety.
• Prepare and report on Key Performance Indices and departmental activities in monthly management reports, SQRT meetings and BSC.
• Manage site prioritization and management escalation meetings regarding AQRTs (Area Quality Review Teams). Preparation of AQRT Executive Summary Reports.
• Driving Quality Assurance & Technical Team engagement, effective communication and development of direct reports
• Ensure compliance with Site Quality management policies, in accordance with Pfizer Quality Standards (PQS).
• Ensure compliance with local/government regulations in relation to quality and safety.
• Ensure compliance with registration details at site and third parties regarding product release.
• Ensure a safe and Safety compliant manufacturing area and quality controls labs.
• Oversee the GMP cleaning program to ensure the program is effective and compliant with Pfizer Quality Standards (PQS).
• Comply and ensure compliance to Health, Safety and Environment policies, guidelines and requirements as applicable by law and Pfizer Corporate Guidelines as a Facility EHS Committee member for QO and perform following activities:
• Ensure the implementation of EHS policies, guidelines and procedures in QO.
• Conduct monthly departmental EHS meeting & prepare the presentation of the meeting.
• Communicate all necessary information that is received from EHS department to relevant QO colleagues.
• Facilitate EHS team in conducting the EHS Audit of the QO.
• Assist in setting and achieving departmental EHS goals and objectives.
• Actively participate in the enhancement of the quality culture within PGS.
• Manage multiple projects and ongoing work activities within the division typically involving cross-functional representatives.
• Manage the specific Inspection preparation plan for key Good Manufacturing Practices {also cGMP} elements etc.
• Provides guidance and coaching to Quality Operations colleagues and provide direction or approval of activities and decisions.
• Provide Quality Assurance expertise to site and external parties as required.
• Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Pfizer's standard processes and quality systems.
• Assist in key site quality behavior establishment, set clear company policies and behavior expectation for team member.
• Prepare departmental budgets and control the departmental cost within the budgets.
• Interface with Regulatory Agencies in audits, track and report metrics for all internal auditing activities.
• Manage and monitor the audit report distribution process to ensure timely delivery of critical information to key stakeholders and complete regulatory commitments
• Assist Quality Operations Deviations and Product Floor Support for all planned and unplanned manufacturing deviations, review and approval of product and equipment change controls.
• Take independent actions and decisions and motivate key stakeholders to deliver quality outcomes for business requirements.

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Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

 

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

The primary purpose of this position is accountable for quality oversight of manufacturing and packaging activities, processes and procedures at site level that ensure compliance with Pfizer Quality Standards, cGMP, applicable regulatory requirements. Provides expertise and guidance in interpreting Pfizer Quality Standards, cGMP, to assure compliance and ensures the quality compliance programs and policies are maintained and updated regularly.

 

To lead activities involved in the batch disposition, and review/approval of product/process related documents to determine if product specifications are met, ensuring that established sampling and statistical process control procedures are followed, identifying and reviewing deviations from established standards in the manufacturing and/or packaging of products, and reviewing and approving investigations to ensure compliance with policies.

As manager at PGS Karachi, keeping the team engaged, focused and aligned on key site priorities will be fundamental to the success.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving

 

About the company

Breakthroughs That Change Patients' Lives: Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. To learn more, visit www.pfizer.com.

For additional information on our guidelines, please visit http://www.pfizer.com/community-guidelines

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