Pfizer

Associate manager - Quality Assurance

Posted 2 Hours Ago

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Ahmedabad, Gujarat, IND

In-Office

Senior level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Leads pharmaceutical quality assurance compliance for Pfizer products manufactured at an external oncology site. Responsibilities include batch record review and release authorization, change control and regulatory impact assessments, complaint investigations, supplier quality management, QMS investigations, validation and technology transfer support, audit participation, training, document management, and oversight of Pfizer digital quality systems.

Summary Generated by Built In

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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control

Skills Required

B. Pharm, M. Pharm, or M.Sc. degree
Minimum 6 years of experience
Strong understanding of quality systems, manufacturing and packaging processes, validations, batch documents, customer complaints, investigations, training management, change controls, and document management
Ability to apply mathematical concepts, including statistics and probability, to quality engineering tasks
Excellent technical writing, communication, and presentation skills
Proficiency in Microsoft Office, Microsoft Project, and statistical software
Experience preparing for and participating in audits and inspections
Experience handling complaints and using electronic laboratory systems
Strong analytical and problem-solving skills
Ability to work independently and collaboratively
Strong interpersonal and communication skills across organizational levels
Ability to adapt to changing priorities and manage multiple tasks
Experience mentoring and training colleagues
Experience using generative AI tools such as ChatGPT or Microsoft Copilot and understanding responsible AI practices

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Healthcare Strength — Official materials describe comprehensive medical, dental, vision, and mental-health support, plus fertility/family‑building and transgender‑inclusive coverage; eligible Pfizer medications are noted as available at no cost in U.S. plans. Wellness resources such as telehealth and preventative programs are also emphasized.
Retirement Support — Company documents highlight a 401(k) with matching contributions plus an additional Retirement Savings Contribution beyond the match. Financial planning support and company‑paid life and disability insurance further bolster long‑term security.
Leave & Time Off Breadth — Corporate pages and job postings describe paid vacation and holidays, caregiver leave, and paid parental leave for both parents. Materials also note that details can vary by role and location.

Learn more about Pfizer's Compensation & Benefits →

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.