Senior QA Specialist (Batch Release)

Senior QA Specialist (Batch Release)

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locations: Singapore - Tuas

time type: Full time

posted on: Posted Yesterday

job requisition id: 4917553

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 evaluate and review Pfizer’s clinical and commercial batches of drugs. You will ensure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards in the manufacturing and packaging of products. In relevant cases, you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Responsible for reviewing and approving master batch records and subsequent batch records associated with the manufacturing, packaging, and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with quality standards and regulatory registered specifications.
• Review QC lab worksheets for intermediates, APIs, and cleaning samples.
• Disposition of the intermediates and active pharmaceutical ingredients (API), including re-evaluation.
• Review and approve cleaning records and procedures and ensure compliance with the Quality Standards and guidelines.
• Support production startup activities including new product introduction (NPI), changeover activities, equipment releases, module clearance, etc.
• Tank farm monitoring and QA oversight of the solvent recovery processes.
• Review and approve GMP documentation and ensure their compliance with Quality Standards.
• Ensure adherence to quality procedures, regulatory requirements, and cGMPs.
• Perform Quality Impact assessment for Change control.
• Perform quality review of material master data setup in SAP and create label templates for intermediates and APIs.
• Write deviations according to the site procedures.
• Coordinate with cross-functional teams to prepare Annual Product Record Review, discuss trends and atypical observations, and recommend improvement actions.
• Support and facilitate the product return process.
• Support internal audits to ensure the internal controls are effective.
• Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walkdowns to ensure site operation and facility are maintained in inspection-ready state.
• Support the maintenance of validated states of GMP systems and processes.
• Support regulatory submissions and attend to regulatory queries in a timely manner.
• QA oversight of site processes and systems e.g., pest control program, warehouse, and engineering.

Qualifications

Must-Have

• Bachelor's degree in science / chemical engineering
• For Senior QA - minimum of 4 years' experience in QA role within the pharmaceutical industry
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards
• Proactive approach and strong critical thinking skills
• Must be able to work in a team environment within own team and interdepartmental teams
• Excellent communication and interpersonal skills
• Good working knowledge of Microsoft Excel and Word

Nice-to-Have

• Master's degree and relevant pharmaceutical experience
• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener
• Effectively manages stressful situations, able to focus on tasks regardless of circumstances and stress-induced pressure

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.

About Us

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.