Associate manager - Quality Assurance

Use Your Power for Purpose

Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.

What You Will Achieve

In this role, you will:

• Overall responsibilities for quality assurance compliance at the Zydus Hospira Oncology Private Limited (ZHOPL) site and Pfizer Quality & ensure sustainable GMP compliance for Pfizer Products manufactured at ZHOPL site as per Quality agreement.

• Batch record review and release authorization compliance functions:
• Responsible for review and authorize the packed batch lot(s) for distribution in respective market from ZHOPL.
• To be part of SQRT as needed for any Batch related issue discussion.

• Regulatory impact assessment for all types of change related to Pfizer products
• Responsible for Review and approval of Change controls at ZHOPL as per the Pfizer requirements.
• Responsible for performing the SCNM (Site Compliance Network Member) activities at ZHOPL and create the PAC and PCF in the PDM systems.
• Responsible for the review and approval of submission package as per procedure REG-459.
• Review BoH Queries & response and compendial/scientific data changes
• Responsible for review and approval for NPL assessment and dossier handover to ZHOPL

• Complaint Management for Pfizer Product
• To coordinate and ensure that ZHOPL comply with the requirements for managing complaint.
• To review and approve the ZHOPL complaint investigation reports and upload investigation reports in the Pfizer electronic complaint database.
• Support for activities including co-ordination committee meeting and share the applicable information/ distribution details to site & & Pfizer market action leader function during market action and mock recall activity.

• Supplier Quality Management
• Assist with supplier related activties for API, excipient & critical processing aid as per Pfizer Quality standards.
• Ad-hoc activities related to supplier.

• Quality Management System (QMS) compliance functions: Assist as required for Review and approval of Investigations (QARs) initiated at ZHOPL.To be part of SQRT and involve in the Investigations.
• To provide Quality support for review of documents for new product launches and Tech transfers as needed 
• Support review of Process validation related documentation performed at ZHOPL.
• Training Management for Team.
• Assisting with QMS related activities, Including GSOP review and assessment and implementation at site and for Pfizer team.

• Other: To support any additional and urgent activity in absence of primary responsible person as assigned by the Manager. As needed to provide Quality support for new product launches and Tech transfer as and when needed.
• Assisting with review and approval of investigations.
• Managing various Pfizer share points and Pfizer digital systems for activities related to support complaints, Change controls, Investigations, supplier management, Etc.

Here Is What You Need (Minimum Requirements)

• B. Pharm/ M. Pharm / M.Sc. with minimum 6+ years of experience
• Strong understanding of Quality System functions, manufacturing and packaging processes, validations, batch documents , customer complaints, investigations, Training management, change controls, document Management.
• Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks
• Excellent technical writing, communication, and presentation skills
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
• Experience in preparing and participating in audits and inspections

Bonus Points If You Have (Preferred Requirements)

• Background in handling complaints and utilizing electronic lab systems
• Strong analytical and problem-solving skills
• Ability to work independently and as part of a team
• Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
• Ability to adapt to changing priorities and manage multiple tasks simultaneously
• Experience in mentoring and training colleagues
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Work Location Assignment: On Premise