QA Batch Release Sr. Associate

Posted 2 Days Ago
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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
Evaluate and approve commercial drug batches for cGMP/GxP compliance; perform sampling and statistical process control; investigate and document QA deviations; assess change controls; provide quality review of site documentation and contribute to projects.
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:
  • Evaluate and review commercial drug batches to ensure compliance with established specifications.
  • Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.
  • Approve investigations and change control activities to maintain compliance with configuration management policies.
  • Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
  • Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
  • Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
  • Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.

Here Is What You Need (Minimum Requirements)
  • Bachelor of Sciences/ Pharmacy with 8+ years of experience or Masters degree with 6+ years of experience with relevant experience in Manufacturing upstream/ downstream operations.
  • Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
  • Strong critical thinking skills
  • Ability to work effectively within own team and interdepartmental teams
  • Good working knowledge of Microsoft Excel and Word
  • Proactive approach to problem-solving

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

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

  • Bachelor of Sciences or Pharmacy with 8+ years experience or Master's with 6+ years experience in manufacturing upstream/downstream operations
  • Solid understanding of current Good Manufacturing Practices (cGMP) and relevant GxP regulations and standards
  • Strong critical thinking skills
  • Ability to work effectively within own team and interdepartmental teams
  • Good working knowledge of Microsoft Excel and Word
  • Proactive approach to problem-solving
  • 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, and understanding responsible AI practices

What the Team is Saying

Daniel
Anna
Esteban
Pfizer

Pfizer Compensation & Benefits Highlights

  • Healthcare Strength Multiple U.S. medical plan options include telehealth, comprehensive mental‑health support, fertility/family‑building benefits, transgender‑inclusive coverage, and certain Pfizer medications at no cost. A Wellbeing Wallet and wellness resources broaden the health and wellbeing offering.
  • Retirement Support A 401(k) with company matching is paired with an additional Pfizer Retirement Savings Contribution, alongside company‑paid life and disability insurance. One‑on‑one financial planning support is provided through Fidelity.
  • Leave & Time Off Breadth Paid time off spans vacation, holidays, and personal days, with additional caregiver and medical leave. U.S. parental leave commonly includes 12 weeks paid with options for additional unpaid bonding time and a return‑to‑work transition.

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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.

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Employees engage in a combination of remote and on-site work.

Typical time on-site: 2.5 days a week
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