Pfizer

Associate Manager - MSAT (C&Q)

Posted Yesterday

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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

Leads pharmaceutical manufacturing validation and qualification activities, including reviewing master plans, protocols, reports, and quality documentation. Troubleshoots equipment and process validation issues, performs data analysis, manages quality systems, coordinates testing, supports audits and product transfers, and investigates deviations. The role covers sterile manufacturing facilities, equipment, utilities, cleaning validation, computerized systems, revalidation, change controls, and regulatory compliance while mentoring colleagues and representing engineering validation teams.

Summary Generated by Built In

Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care.
What You Will Achieve
In this role, you will:

Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.
Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
Guide the writing, review, and approval of validation process documents and technical reports, ensuring adherence to the latest Pfizer Quality Standards.
Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups.
Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams.
Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.

Here Is What You Need (Minimum Requirements)

High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
Proven expertise in Good Manufacturing Practices
Strong working knowledge of various quality systems and processes
Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System
Excellent verbal and written communication skills
Ability to work independently and in a team environment

Bonus Points If You Have (Preferred Requirements)

Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
Experience with sterile products and medical devices
Strong analytical and problem-solving skills
Strong organizational and time management skills
Ability to mentor and guide other colleagues
Experience in regulatory audits and compliance
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

Essential Requirements:

Preferred Education/ Qualification: B. Pharm/ M. Pharm/ B Tec/ BE
Experience: 6-8 years of experience in Quality Assurance / Validation function / Engineering of sterile dosage form facility / Production of Injectable formulations to cater regulated market.
Understanding of pharmaceutical manufacturing, packaging and quality assurance operations.
Knowledge of validation principles and practices related to the following areas: manufacturing process, cleaning methods, facility, equipment, utility system, and CSV systems.
Conversant with design & working principles of key equipment used in sterile manufacturing -Autoclave, Vial washing, Depyrogenation tunnel, Vail filling, stoppering and sealing, Solution preparation, Filter integrity testing devices, Visual inspection equipment, Packing equipment, and Cleaning Validations.
Compile validation documents and results.
Develop facility qualification reports.
Knowledge on the Validation concepts and ability to train the people.
Preparation of the traceability matrix.
Review of DQ, FAT/SAT activities/documents Preparation, participation and review of qualification documents (i.e. IQ / OQ/ PQ protocols, etc.) and Reports.
Preparation and execution of spread sheet qualification protocols.
Ensure revalidations are performed within the established intervals.
Coordination of validation execution with CFT.
Performing Alarm assessment during qualification.
Performs Data analysis and review.
Review and investigation of qualification deviations.
Execution and review of IQ/OQ/PQ protocols and Reports.
Problem Solving: Ability to investigate, identify root cause and preventative measure using DMAIC tool and other appropriate tools.
Experience in plant and TS operations.
Good document review skills, data analysis with ability to identify issues and recommend actions
Knowledge on the Qualification instruments and Tools.
Knowledge on the GAMP requirements, PDA guidance, ISO guideline, 21 CFR part 11.
Knowledge on the Components level assessment, PM requirement.
Good knowledge on the Validation instruments calibration.
Knowledge on the assessment of the Change controls and failure investigations.
cGMPs and FDA regulatory guidelines.
Awareness of safety at working place

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

High school diploma or equivalent with 8+ years of relevant experience
Associate degree with 6+ years of relevant experience
Bachelor's degree with 2+ years of relevant experience
MBA or MS with relevant experience
6–8 years of experience in Quality Assurance, validation, engineering of sterile dosage-form facilities, or injectable formulation production
Proven expertise in Good Manufacturing Practices
Strong working knowledge of quality systems and processes
Familiarity with Global Document Management System, SAP, and Quality Tracking System
Excellent verbal and written communication skills
Ability to work independently and in a team environment
Knowledge of pharmaceutical manufacturing, packaging, and quality assurance operations
Knowledge of validation principles for manufacturing processes, cleaning methods, facilities, equipment, utilities, and computerized systems
Experience with sterile manufacturing equipment and cleaning validation
Knowledge of validation concepts and ability to train personnel
Experience preparing traceability matrices, facility qualification reports, and validation documents
Experience with DQ, FAT/SAT, IQ/OQ/PQ protocols and reports
Experience preparing and executing spreadsheet qualification protocols
Knowledge of revalidation intervals, alarm assessment, qualification deviations, and data analysis
Experience coordinating validation execution with cross-functional teams
Experience investigating root causes and preventive measures using DMAIC or similar methods
Experience in plant and technical services operations
Knowledge of qualification instruments, tools, calibration, component-level assessments, and preventive maintenance requirements
Knowledge of GAMP requirements, PDA guidance, ISO guidelines, 21 CFR Part 11, cGMPs, and FDA regulatory guidelines
Knowledge of change control and failure investigation assessment
Awareness of workplace safety
B.Pharm, M.Pharm, B.Tech, or B.E.
Experience validating pharmaceutical processes, equipment, utilities, facilities, or computer systems
Experience with sterile products and medical devices
Experience with regulatory audits and compliance
Strong analytical, problem-solving, organizational, and time-management skills
Ability to mentor and guide 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.

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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.