Senior Associate - Tech Transfers

Pfizer; India; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Pfizer India is seeking a qualified validation professional to drive tech transfer, development batches and process validation, ensuring regulatory submissions meet Pfizer standards.

You will evaluate validation master plans, protocols, and reports, troubleshoot issues, and provide data-driven support for QA investigations. The role also involves maintaining quality systems and coordinating cross-functional validation activities to support production and audits.

Qualifications

• Bachelor or higher qualifications with relevant validation experience in pharma/biotech.
• Experience in tech transfer, exhibit batches and process validations.
• Familiarity with FDA regulations across multi-market operations.
• Strong knowledge of GMP and quality systems.
• Excellent communication and ability to work independently and in teams.

Responsibilities

• Lead tech transfer of new molecules, exhibit batches, and process validation activities.
• Review and approve validation master plans, protocols, and reports for compliance.
• Troubleshoot validation issues affecting equipment and processes.
• Perform statistical analysis of testing results and support QA investigations.
• Guide writing and approval of validation documents and technical reports.
• Manage Change Control, Quality Agreement, Documentation, and Investigations.
• Coordinate validation testing with production and other functions; support audits.

Skills

Verbal & written communication

Analytical thinking

Problem-solving

Organizational skills

Time management

Teamwork

Education

High school diploma with 8+ years experience

Associate's degree with 6+ years experience

BA/BS with 2+ years

MBA/MS with any years

Tools

Global Document Management System

SAP (System Applications & Products)

Quality Tracking System

Job description

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:

• Tech transfer process of new molecules, developmental studies exhibit batches, Process validation & regulatory Submissions.
• 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
• Experience in tech transfer process scale ups, Exhibit batches & process validations.
• Handling multi-market FDA regulations.
• 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

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