QA Specialist (Batch Release)

at  Pfizer

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 evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

POSITION SUMMARY

• Drive quality culture and promote GMP compliance behaviors to the site.
• Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines.
• Provide QA oversight to the site GMP operations to ensure products produced in compliance with the Pfizer Quality Standards (PQS).
• Collaborate with cross functional teams to improve quality systems.
• Understand regulatory expectations and support site inspection readiness.
• Work with supply chain and drug product sites to ensure timely delivery of quality products.
• Work with GCMC to file products and address regulatory queries in an accurate and timely manner.
• Require working on rotating shift.

How You Will Achieve It

• Responsible to review and approve 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 Pfizer quality standards and regulatory registered specifications.
• Disposition the intermediates and active pharmaceutical ingredients (API).
• Review and approve cleaning records and procedures and ensure compliance with the Pfizer Quality Standards (PQS) and guidelines.
• Support production startup activities, changeover activities, equipment releases, module clearances etc
• Tank farm monitoring and QA oversight of the solvent recovery processes.
• Review and approve GMP documentation and ensure their compliance to Pfizer Quality Standards (PQS).
• Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Perform Quality Impact assessment for Change control.
• Improve quality assurance systems, as necessary.
• Write deviations according to the site procedures. Ensure issues are escalated according to the Pfizer Quality Standards (PQS).
• Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
• Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
• 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 walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner
• QA oversight of the pest control program

Qualifications

Must-Have

• Bachelor’s Degree/Diploma in Science/Chemical Engineering or equivalent
• Experience in pharmaceutical industry
• Experience in Quality administered systems
• Sound knowledge of current Good Manufacturing Practices {part of GxP}
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills

Nice-to-Have

• Experience at a manufacturing site
• Experience of writing reports
• Experience in production batch record review, Enterprise Resource Planning system, campaign changeover, startup support and change control management

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

Please refer the Job description for details