Senior QA Specialist

Pfizer; Johor; Presencial; MYR 120.000 - 180.000; Jornada completa

Descripción de la vacante

Pfizer Malaysia seeks an experienced Quality Assurance professional to ensure GMP and GxP compliance across manufacturing, packaging and labelling activities. The role focuses on batch record reviews, API disposition, and control of GMP documentation within a validated quality system.

You'll contribute to regulatory readiness, drive improvements, mentor junior colleagues, and support internal audits and external inspections as part of Pfizer's commitment to patient safety and product quality.

Formación

• Diploma with 8+ years of relevant experience, or Associate with 6+ years, or BA/BS with 4+ years.
• Solid understanding of GMP and GxP regulations.
• Strong critical thinking skills.
• Ability to work effectively within own team and interdepartmental teams.
• Proactive approach to problem-solving.

Responsabilidades

• Review and approve master batch records and executed batch records for manufacturing, packaging and labelling.
• Perform disposition of intermediates and APIs.
• Review and approve GMP documents, including SOPs, protocols, reports, and change controls.
• Maintain quality systems, support regulatory submissions and inspections.
• Escalate issues per Pfizer guidelines and mentor junior QA staff.

Conocimientos

Critical thinking

Teamwork

Problem solving

Attention to detail

Educación

Diploma / 8+ yrs

Associate degree / 6+ yrs

BA/BS / 4+ yrs

Herramientas

Veeva Vault QMS

SAP

Descripción del empleo

Use Your Power for Purpose Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

What You Will Achieve

• Review and approve master batch records and executed batch records for the manufacture, packaging, and labelling of intermediates and active pharmaceutical ingredients (APIs), ensuring compliance with Pfizer quality standards and registered regulatory specifications.
• Perform disposition of intermediates and active pharmaceutical ingredients (APIs).
• Review and approve cleaning instructions and records to ensure compliance with Pfizer global and local documents.
• Review and approve GMP documents, including SOPs, protocols, reports, and change controls, to ensure compliance with Pfizer global and local documents.
• Ensure compliance with quality procedures, regulatory requirements, and current Good Manufacturing Practices (cGMPs).
• Review and approve deviations in accordance with site procedures, including investigation reports, root cause analyses, corrective and preventive actions, and impact assessments conducted with subject matter experts for quality, validation, stability, and regulatory considerations.
• Escalate issues in accordance with Pfizer global and local documents.
• Serve as the Designated Point of Contact (DPOC) and super user for assigned site platforms supporting quality systems, such as Veeva Vault QMS and SAP, when nominated.
• Maintain quality tracking systems and metrics to proactively identify trends and atypical observations.
• Support preparation of the Annual Product Record, evaluate trends and atypical observations, and recommend improvement actions.
• Participate in process risk assessments, such as Failure Modes and Effects Analysis (FMEA), for new product introductions and process changes.
• Assess site procedures against Pfizer global and local documents, recommend actions to close identified gaps and mitigate risks, and conduct internal audits to confirm the effectiveness of internal controls.
• Maintain inspection readiness and support regulatory and customer inspections.
• Participate actively in GMP walkthroughs to ensure site operations and facilities remain inspection ready.
• Support the maintenance of GMP systems and processes in a validated state.
• Support regulatory submissions and respond promptly to regulatory queries.
• Uphold Pfizer's Code of Conduct and values, demonstrate actionable attributes.
• Contribute actively within the assigned Value Stream Team (VST) by reporting performance against metrics, identifying and resolving issues, escalating as appropriate, and developing and implementing effective solutions.
• Lead improvements to Quality Assurance systems, as required.
• Mentor junior members of the Quality Assurance team, including interns.
• Participate actively in safety initiatives and conduct Environment, Health and Safety (EHS) investigations, as required.

Here Is What You Need (Minimum Requirements)

• Diploma with 8+ years of relevant experience or associate’s degree with 6+ years of relevant experience or BA/BS with 4+ years of relevant experiences
• Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
• Strong critical thinking skills
• Ability to work effectively within own team and interdepartmental teams
• Proactive approach to problem-solving

Bonus Points If You Have (Preferred Requirements)

• Experience in quality administered systems
• Strong organizational skills and attention to detail
• Experience with regulatory compliance and documentation
• Ability to mentor and review the work of other colleagues
• Experience using common AI tools, including generative technologies such as 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 Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.