Senior Associate - Tech Transfers

Pfizer; Visakhapatnam; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Pfizer in Visakhapatnam is seeking a validation professional to manage tech transfer activities for new molecules, development studies, and process validations. You will evaluate master plans, protocols, and reports to ensure compliance with Pfizer standards and regulatory requirements.

Responsibilities include troubleshooting validation issues, performing data analysis, and guiding documentation for validation reports.

Qualifications

• Must have exposure to tech transfer scale ups, exhibit batches and process validations.
• Experience in multi-market FDA regulations and GMP compliance.
• Strong knowledge of quality systems and associated processes.
• Familiarity with enterprise information systems used in QA/QC.
• Experience in regulatory audits and compliance activities.
• Ability to work independently and in a team environment.

Responsibilities

• Lead tech transfer activities for new molecules and development batches.
• Review and approve validation master plans, protocols, and reports per Pfizer standards.
• Troubleshoot validation issues across equipment and processes.
• Perform statistical analysis of testing data and process deviations.
• Guide writing, review, and approval of validation documents and technical reports.
• Contribute to mid-complex projects and manage short-term work plans.
• Oversee Change Control, Quality Agreement, Documentation, and Investigations.
• Support regulatory audits and participate in site/network validation activities.
• Assist in product transfers, new product development and cleaning validation.

Skills

Tech transfer

FDA regulations

GMP

Quality systems

Communication skills

Independent/Team work

Information systems

Regulatory audits

AI tools

Education

High school diploma + 8+ years experience

Associate’s degree + 6+ years experience

BA/BS + 2+ years experience

MBA/MS with relevant experience

Tools

Global Document Management System

SAP

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.

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