QA Specialist

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. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

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.
- 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.
- Handle product complaints. Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
- 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.
- 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. 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
- 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.

**Qualifications**:

- Bachelor Degree in Science/Chemical Engineering or equivalent.
- For Senior QA Specialist: A minimum of 3 years’ experience in Quality Assurance role within the pharmaceutical industry
- For QA Specialist: A minimum of 1 year experience in pharmaceutical industry or related industry.
- 3+ years' experience
- Experience in Quality administered systems
- 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

Work Location Assignment: Flexible

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

LI-PFE