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. 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 an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

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

How You Will Achieve It

• Responsible for ensuring an operating state of cGMP compliance in terminal sterilization, visual inspection, and packaging operations.
• Maintain regulatory compliance in accordance with cGMP practices.
• Ensure manufacturing policies and procedures conform to Pfizer's standards.
• knowledge and hands-on experience in reviewing EBR and assessing the impact of AMPs exceptions with technical support/input from a Sr. Specialist or Supervisor.
• Review of batch reports and equipment audit trails
• Perform Acceptable Quality Level sampling, inspection and recording the results in batch records for all products.
• Perform batch start-up and end activities viz. sensor challenge tests, recipe review etc.
• Perform random process checks for terminal sterilization, visual inspection, and packaging.
• perform daily walkthroughs and report observations to the supervisor.
• Perform equipment breakdown assessments w.r.t to product quality and patient safety with technical support/input from a Sr. Specialist or Supervisor.
• Review and assessment of equipment alarms and review of quarterly alarm trends.
• Report any non-compliance to the supervisor.
• should have troubleshooting abilities in the manufacturing area, which helps the organization to develop, implement, and achieve its mission, vision, and values.
• Identify gaps and get involved in process and procedure simplification, thereby reducing downtime and increasing efficiency.

Qualifications

Must-Have

• Bachelor's Degree
• 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 and managing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management

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
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