QA Supervisor

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.

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
- Write, approve and review working procedures for the QA.
- Manage the manufacturing support, cleaning and batch release, new product introduction activities and compliance/regulatory request.
- Plan and control manufacturing support and supply requirement. This includes but not limited to creating standard work, schedules, monitoring the schedule adherence and making any required adjustments to the schedule to deal with changes in manufacturing plan and supply demand.
- Supervise QA personnel in manufacturing support end to end activities.
- Conduct training to increase s knowledge and understanding of regulatory requirements, PQS, Good Manufacturing Practices (GMP) requirements and ALCOA.
- Participate and lead site teams/projects e.g. Safety, continuous improvement, manufacturing support and QA Oversight
- Work closely with Quality Operation, Production, Engineering, Warehouse and Supply chain personnel to support them in QA oversight, supply demand planning and system troubleshooting when required.
- Update and optimize QA resources and capacity utilization
- Develop the skills and capabilities of QA Specialists.
- Engage and inspire the teams on performance expectations and coach the team to meet those expectations using Coaching Skill principles.
- Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.
- Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach the teams.
- Be accountable for the Good Data Management and Data integrity understanding and performance of the team.
- Lead and support continuous improvement efforts, where applicable.
- Be a role model to support a positive compliance culture.

**Qualifications**:
Must-Have
- Bachelor's Degree with minimum 6 years of directly related experience in pharmaceutical manufacturing and quality operations, or equivalent combination of work experience and education.
- Minimum 2 years in a supervisory capacity.
- Experience in an API manufacturing plant is preferred.
- Related experience different pharmaceutical manufacturing facilities is also preferred.

Job Related Requirements:

- Demonstrated record of successful interaction with global regulatory agencies (e.g., FDA, HSA, MHRA) and other internal and external auditing groups.
- Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing.
- Thorough knowledge and understanding cGMP, GAMP, validation principles, and applicable regulations related to validation principles.
- Excellent verbal, written and interpersonal communication skills.
- Demonstrated ability to interact effectively with senior management, auditors, and regulators.

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

LI-PFE