Pfizer

Associate Manager - QA

Posted Yesterday

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Vizag, Vishākhapatnam, Andhra Pradesh

Hybrid

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

The Associate Manager - QA will ensure compliance in drug production, manage quality assurance projects, evaluate drug batches, and perform regulatory reviews and investigations in line with cGMP standards.

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 clinical and 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)

Education Qualification: B. Pharm / M.Pharm / M.Sc (Any Specialization)
Experience: 8 - 10 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.
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, procedures conform to Pfizer
SME for Terminal Sterilization/Visual Inspection/Packing.
Knowledge and hands on experience in reviewing eBR.
Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging
Perform Daily walkthroughs and report observations to the Supervisor and ensure appropriate closure of those incidents
To provide trainings to colleagues on Terminal Sterilization/Visual Inspection/Packing process and equipment.
Report any non-compliance to the Supervisor
To perform manufacturing investigations, implementation of CAPAs and to provide support to other investigators for technical inputs.
Provides guidance to and may lead moderate to complex projects
Identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime and increase the Efficiency.
Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
Experience in handling regulatory, corporate and internal auditors/ inspectors
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.
Quality Assurance and Control

Top Skills

Excel

Microsoft Word

What the Team is Saying

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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.