Senior Associate - Tech Transfers

Role overview

Senior Associate - Tech Transfers at Pfizer

In this role, you will:

Responsibilities

• Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
• Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups.
• 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.
• Work Location Assignment: On Premise

Employment details

• Location: India - Vizag

Application details

• Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System
• 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 .

About the employer

• Guide the writing, review, and approval of validation process documents and technical reports, ensuring adherence to the latest Pfizer Quality Standards.
• Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Additional role details

• 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
• Tech transfer process of new molecules, developmental studies exhibit batches, Process validation & regulatory Submissions.
• 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.
• Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
• Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams.
• 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
• 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
• Quality Assurance and Control