Job Description

• Responsible for ensuring operating state of cGMP compliance in solution/emulsion preparation, vial/ampoule washing, depyrogenation, filling and capping operations.
• Maintain regulatory compliance in accordance with cGMP practices.
• Ensure manufacturing policies and procedures conform to Pfizer standards.
• Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from supervisor.
• Review of batch reports and equipment audit trails.
• Perform EMS alarm impact assessments and monthly trend reports.
• Ensure start-up and in-process activities performed as per batch record and SOP compliance.
• Monitor and adherence manufacturing practices with respective standards and approved procedures.
• Perform daily walk throughs and report observations to the supervisors and ensure appropriate closer of those incidents.
• Perform equipment breakdown assessments w.r.t to product quality and patient safety independently.
• Review and approval of equipment alarms and review of alarm trends.
• Report any non-compliance to the supervisor.
• Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
• Identify gaps and involve in process and procedure simplification, thereby reduce downtime and increase the efficiency.
• Experience in handling regulatory, corporate and internal auditors / inspectors.
• Responsible for assisting manufacturing investigators w.r.t collection of data, information and technical support and may perform in conducting investigations.

Education: B. Pharma / M. Pharma / M.Sc.

Experience: 1-5 years\xe2\x80\x99 experience in Manufacturing Quality Assurance / Quality Assurance/ Production of a pharmaceuticals manufacturing facility.

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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Pfizer