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 and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.

This position is a member of the Medical Device and Combination Products (MDCP) Quality Operations team within the Pfizer Global Supply (PGS) organization and provides end-to-end quality assurance support to Pharmaceutical Sciences, Commercial Sites and Global Technical Engineering and Launch (GTEL) for the development, commercialization, and post-launch support of packaging for Pharmaceutical, Combination and Medical Device Products.  The incumbent provides quality assurance guidance of Packaging and Labelling for Pharmaceutical, Combination Products and Medical Devices throughout the product lifecycle including development, clinical trials, vendors, complaints, post-market surveillance, regulated body inspections, applicable internal procedures, and other applicable regulatory requirements throughout the product lifecycle. 

How You Will Achieve It

• Act as the quality assurance packaging and labelling quality lead supporting products through reviews and approvals of all product lifecycle documentation including development, risk management, quality management systems, change controls, vendor management, and complaints.
• Ensure packaging design, development, commercialization, complaint, and manufacturing documentation of pharmaceutical products, medical devices and combination products meet appropriate regulatory requirements by providing guidance through all stages of life cycle management in accordance with packaging regulations, standards and in compliance with Pfizer Policies, Global Standards Operating Procedures (GSOPs) and Global Work Instructions (GWI’s). 
• Serve as Owner and subject matter expert (SME) on packaging Global Standard Operating Procedures (GSOPs) and Global Work Instructions (GWIs), internal procedures. 
• Provide support for packaging and labelling related quality investigations related to Corrective Actions Preventative Actions (CAPAs), laboratory investigations, external suppliers, or complaints. 
• Responsible for working with external contractors related to packaging ensuring consistency and compliance with regulatory expectations and company standards including leading and supporting investigations of significant quality and/or regulatory events associated with external suppliers. 
• Monitors changes to packaging and labelling global regulations and ensures policies and procedures reflect applicable changes, implements packaging best practices, and communicates company-wide policies on packaging effectively. 
• Identifies, leads development of, and participates in implementation of new processes/programs for packaging continuous improvement. 
• Provide support for audits and inspections by FDA, notified bodies, competent authorities, and other third parties for packaging related issues.
• Lead execution of packaging test method development, test method validation, and design verification/validation related test protocols.
• Advise on packaging related test plan writing and execution for design verification/validation and process validation.
• Monitor changes to global packaging regulations and ensure policies and procedures reflect applicable changes, implements quality system best practices, and communicates company-wide policies effectively.
• Responsible for quality oversight of packaging: design verification and validation, usability, process qualification and change control execution, and continuous improvement of the same.
• Packaging Quality Assurance oversight of facility, equipment, computer sy