Senior Associate - Tech Transfers

Pfizer, S.A. de C.V; Hinoba-an; On-site; PHP 1,000,000 - 1,800,000; Full time

Job summary

Pfizer Global Supply seeks an experienced QA/Validation professional to lead tech transfer, validation of processes, and regulatory submissions. You will review validation plans, troubleshoot issues, and ensure adherence to Pfizer quality standards.

Role requires strong communication, ability to work independently and in teams, and experience with GMP-compliant documentation and QA investigations. The position is based in the Philippines with onsite responsibilities.

Qualifications

• High school diploma or equivalent with 8+ years of experience, or associate’s degree with 6+ years, or BA/BS with 2+ years, or MBA/MS with relevant experience.
• Experience in tech transfer process scale ups, Exhibit batches and process validations.
• Strong working knowledge of quality systems and processes.
• Familiarity with information systems such as Global Document Management System, SAP, and Quality Tracking System.
• Excellent verbal and written communication skills.
• Ability to work independently and in a team environment.

Responsibilities

• Tech transfer of new molecules, development batches, process validation and regulatory submissions.
• Review and approve validation master plans, protocols, and reports for compliance.
• Troubleshoot validation issues for equipment and processes; provide resolution expertise.
• Conduct statistical analysis of testing results and process anomalies for QA investigations.
• Guide writing, review, and approval of validation documents and technical reports to Pfizer quality standards.
• Contribute to medium-complexity projects and develop short-term work plans.
• Manage routine quality systems including Change Control and Investigations; coordinate testing.
• Support regulatory audits and participate in site/network teams.

Skills

Tech transfer

Process validation

Quality systems

Statistical analysis

Regulatory submissions

Documentation

Problem solving

Communication

Education

High school diploma

Associate's degree

BA/BS

MBA/MS

Tools

Global Document Management System

System Applications & Products

Quality Tracking System

Job description

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

Pfizer, We are one

PGS - Manufacture the Future

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.
• 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, includingrisk management and ethical use

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