Pfizer

Sr. Associate Quality Assurance

Posted 9 Days Ago

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Vizag, Vishākhapatnam, Andhra Pradesh, IND

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 role involves evaluating drug batches for compliance, conducting sampling, managing change control activities, and ensuring regulatory compliance in drug manufacturing.

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)

Bachelor's Degree in Sciences/ Pharmacy with Minimum 6 to 8 years in Pharma/ Biotech / Master's Degree in Sciences/ Pharmacy with Minimum 5 to 7 years in Pharma/ Biotech
Change Management process
Risk assessments principles and tools
Validation of manufacturing equipment's
Drug Product Process validations
Regulatory requirements

Bonus Points If You Have (Preferred Requirements)

Strong Interpersonal skills
Ability to communicate effectively with all levels within the organization.
Compliance driven approach , knowledge on cGMP and regulations.
Knowledge in validation principles and practices related to the Equipment & Utility Qualifications, Water system, HVAC system.
Understanding of Drawings and layouts of manufacturing area, air flow, material flow, personal flow, building management system for real-time monitoring of manufacturing areas.
Fundamental knowledge on manufacturing activities like dispensing, solution preparation , filling, terminal sterilization, visual inspection, labelling and packing.
Understanding of design and engineering aspects, basic knowledge of equipment construction, working principle and maintenance of equipment.
Knowledge of various Quality tools required for investigations
Technical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organization.
Knowledge in Change control assessment
Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship.
Managerial Skills: Persistent approach to resolving issues, Effective situation handling capabilities, strong time management skills.
Written communication: Ability to write well-Structured technical reports.
Holds people accountable: Clearly assigns responsibility for tasks and decisions; sets clear objectives and measures; Monitors process, progress and results
Acts Decisively: Makes decision m a timely manner based on available information.
Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives
• Grows others: Provides challenging and stretching tasks and assignments.
Self-accountable & Proactive approach.
Critical thinking and Compliance mindset.

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

Skills Required

Bachelor's Degree in Sciences/Pharmacy with Minimum 6 to 8 years in Pharma/Biotech
Master's Degree in Sciences/Pharmacy with Minimum 5 to 7 years in Pharma/Biotech
Change Management process
Risk assessments principles and tools
Validation of manufacturing equipment
Drug Product Process validations
Regulatory requirements

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Parental & Family Support — U.S. materials describe up to 26 weeks of parental leave (including up to 12 paid non‑medical weeks), with phased return‑to‑work plus fertility, adoption, and surrogacy financial support, backup care, lactation support, and caregiver leave. These offerings indicate depth in family‑building benefits and day‑to‑day caregiver resources.
Healthcare Strength — Core programs commonly include medical, prescription drug, dental, vision, mental‑health/EAP resources, disability insurance, preventive health programs, and free or reduced‑cost vaccinations. Voluntary Benefit Extras and wellness resources broaden coverage and access.
Retirement Support — Career pages and postings note a 401(k) with company matching plus an additional company retirement savings contribution in some plans. Company materials also reference financial‑planning education and colleague‑directed retirement funds.

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.