Senior 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 and control team. You will be responsible for activities involved in quality oversight for change control system, product change control oversight with Regulatory Affairs and APR program management. You will also be relied on to support non-manufacturing functions, quality strategic planning, performance metrics and quality goals and objectives. You will also quality provide related oversight for other functions.

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 in 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
- Handle product complaints. Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
- 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.
- Prepare Annual trend for deviations and Product Complaints
- 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.
- 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.
- 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**:
Must-Have
- Bachelor's Degree in Science/Chemical Engineering or equivalent.
- 4+ years' experience in Quality Assurance role within the pharmaceutical industry
- Strong written and verbal communication skills

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