Pfizer

Associate Manager MQA

Posted 4 Hours Ago

Be an Early Applicant

Vizag, Vishākhapatnam, Andhra Pradesh, 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

Ensure cGMP compliance for terminal sterilization, visual inspection, and packaging operations. Review eBRs, AMPS/recipe exceptions, batch reports, and equipment audit trails. Perform AQL sampling, start-up/end activities, process checks, walkthroughs, alarm trend reviews, and equipment breakdown/product quality assessments. Troubleshoot manufacturing issues, drive process simplification to reduce downtime, and support regulatory inspections.

Summary Generated by Built In

Use Your Power for Purpose
Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve
In this role, you will:

Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.
Maintain regulatory compliance in accordance with cGMP practices
Ensure manufacturing policies and procedures conform to Pfizer standards.
Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Team leader.
Review of Batch reports, and Equipment audit trails
Perform Acceptable Quality level sampling, Inspection and record the results in Batch records for all products.
Perform batch start-up and end activities viz. sensor challenge tests, recipe review etc.
Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging.
Perform Daily walkthroughs and report observations to the Sr. Team leader.
Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Team Leader.
Review and assessment of equipment alarms and review of quarterly alarm trends.
Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
Identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime, and increase the Efficiency. AMPS Recipe review and validation of recipe.
Experience in handling regulatory, corporate and internal auditors/ inspectors

Here Is What You Need (Minimum Requirements)

B. Pharm, M. Pharm, MSc.
6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.
Fundamental knowledge of terminal sterilization process/ Visual Inspection/Packaging.Should be capable of handling regulatory inspections USFDA/MHRA/TGA, etc.,
Ability to work effectively within own team and interdepartmental teams
Good working knowledge of Microsoft Excel and Word
Proactive approach to problem-solving
Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship
Acts Decisively: Makes decision in a timely manner based on available information
Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives Critical thinking and Compliance mind set.

Bonus Points If You Have (Preferred Requirements)

Experience in quality administered systems
Strong organizational skills and attention to detail
Experience with regulatory compliance and documentation
Ability to mentor and review the work of other 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

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 MSc degree
6-8 years experience in Manufacturing Quality Assurance or Production in a pharmaceutical manufacturing facility
Fundamental knowledge of terminal sterilization, visual inspection, and packaging processes
Experience handling regulatory inspections (e.g., USFDA, MHRA, TGA)
Hands-on experience reviewing electronic batch records (eBR) and assessing AMPS/recipe exceptions
Ability to perform AQL sampling, batch start-up/end activities, and equipment/process checks
Troubleshooting skills in manufacturing environments
Experience interacting with regulatory, corporate and internal auditors/inspectors
Proficiency with Microsoft Excel and Word
Strong communication, teamwork, problem-solving, critical thinking and compliance mindset
Experience in quality administered systems
Experience mentoring or reviewing colleagues' work
Experience using AI tools (e.g., ChatGPT, 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 →

Pfizer Insights

What's It Like to Work at Pfizer? Pfizer Culture & Values Pfizer Career Growth & Development What's the Work-Life Balance Like at Pfizer? Pfizer Leadership & Management Pfizer Company Growth, Stability & Outlook

View all jobs at Pfizer

View Pfizer Profile

Report Job

Am I A Good Fit?

beta

Get Personalized Job Insights.

Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

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.