Job Description

Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will drive quality culture and promote compliance behavior. You will collaborate with cross functional team to improve quality system. You will provide adequate quality oversight to supplier management to ensure materials used meet Pfizer Quality Standards (PQS). You will be involve in the logistic of inspection for Pfizer Tuas. Ensure Site is ready for inspection.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It

• Review and approve GMP documentation and ensure their compliance to Pfizer Quality Standards (PQS).
• Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Improve quality assurance systems, as necessary.
• Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
• Conduct internal audits to ensure the internal controls are effective. Conduct external audits to ensure adequate oversight to suppliers and collaborate with supplier to reduce starting material quality issues.
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Support regulatory submissions and attend to regulatory queries in a timely manner
• Qualify and manage suppliers according to Pfizer Quality Standards (PQS) and maintain accurate records of supplier status. Review and analyze the quality related issues from suppliers and recommend improvement action to mitigate compliance risk to Pfizer.
• Ensure supplier and material is qualified timeline to support production schedule.
• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Create, review and approve Good Manufacturing Practices {also cGMP} audit reports.
• Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
• Create, review and approve deviations and consistently produce quality work.
• Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues
• Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
• Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.
• Lead/Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.

Qualifications
Must-Have

• Degree holder in Science / Chemical Engineering or equivalent
• Has working experience of at least 2 years
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills
• Is able to collaborate with cross functional department

Nice-to-Have

• Is able to work independently
• able to analyze data and information

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
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