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, Documentation, and Investigations, and coordinate testing with functional groups.

• Maintain the Site Validation Master Plan, support regulatory audits, and represent validation on site or network teams.

• Support product transfers/new product development, regulatory queries, and cost improvement projects.

• Ensuring integration of validation schedules in production and participating in deviation investigations.

• Maintain and manage of Continued process verification (CPV) and Periodic Cleaning Monitoring (PCM)

Here Is What You Need (Minimum Requirements)

• You hold a degree in pharmacy, pharmaceutical technology or comparable scientific discipline.

• Minimum two years of experience in pharmaceutical industries combined with strong knowledge of regulatory requirements, GMP, and pharmaceutical development processes.

• Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems

• Excellent verbal and written communication skills

• Ability to work independently and in a team environment

• Ability to work under pressure and adapt to a fast-paced environment

• Strong analytical and problem-solving skills

• Strong organizational and time management skills

• Willing to be placed in Jakarta

Bonus Points If You Have

• Strong working knowledge of various quality systems and processes

• Ability to mentor and guide other colleagues

• Experience with Solid Oral Dosage/Semi-Solid Dosage/Liquids Dosage forms

• Lean Six Sigma Yellow Belt or Green Belt certification

  
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