Validation/Qualification Officer

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, 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. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.

What You Will Achieve

In this role, you will:

• Develop and maintain qualification and validation strategies.
• Support the update of the Site Validation Master Plan.
• Prepare, execute, and review qualification and validation documentation.
• Coordinate cleaning validation activities, including protocol preparation, report issuance, and runs scheduling.
• Coordinate process validation and holding time validation activities.
• Track qualification and validation schedules to ensure timely completion.
• Participate in periodic requalification and qualified state assessments of equipment and utilities.
• Create, revise, and maintain GMP documentation under QA responsibility.
• Participate in investigations related to qualification and validation anomalies.
• Contribute to the preparation and revision of procedures related to qualified equipment and validated processes.
• Support deviation, change control, and CAPA processes, including impact assessments and effectiveness follow-up until closure.
• Act as backup for the Quality System Specialist when required.
• Support QA departmental activities, KPI monitoring, compliance initiatives, and continuous improvement programs.

Here Is What You Need (Minimum Requirements)

• Pharmacist, master’s degree, or equivalent qualification in Pharmacy, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Quality Assurance, or a related scientific discipline.
• Minimum of 3 years Experience in the pharmaceutical industry, Quality Assurance.
• Sound knowledge of current Good Manufacturing Practices (part of GxP)
• Ability to work effectively in a team environment, both within one's own team and interdepartmental teams.
• Effective written and oral communication skills.

Bonus Points If You Have (Preferred Requirements)

• Experience at a manufacturing site.
• Master's specialization in Pharmaceutical Quality Assurance is preferred.
• Experience in qualification, validation, deviation management, change control, CAPA management, and GMP documentation.
• Experience supporting continuous improvement and GMP training initiatives.
• Strong problem-solving skills.
• Ability to work independently and as part of a team.
• Excellent time management and multitasking abilities.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhancement.

  
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