Roles and responsibilities:
- Responsible for ensuring operating state of cGMP compliance in Solution/Emulsion preparation, vial/ampoule washing, Depyrogenation, Filling, Capping and Collection 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 (Electronic Batch Record) and assessing the impact of AMPS (Agile manufacturing production system) exceptions with technical support/inputs from supervisor.
- Review of batch reports and equipment audit trails.
- Perform Alarm impact assessment, review and approval of trend reports.
- Ensure start-up and in-process activities performed as per batch record and compliance to Standard Operating Procedure.
- Monitor and adherence manufacturing practices with respective standards and approved procedures.
- Perform CCTV (Close Circuit Television) monitoring to oversight the activities in manufacturing process area.




- Perform daily walk throughs as per clean room behavior/Coaching program and report observations to the supervisors and ensure appropriate closer of those incidents.
- Perform equipment breakdown assessments and ensure product quality and patient safety independently.
- Report any non-compliance to the supervisor.
- Responsible for performing manufacturing investigations, implementation and approved investigation CAPA
- undefined
- Manage investigation and apply relevant and necessary actions/ systems to ensure appropriate closure of those incidents.
- 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 for colle

📌 Associate Manager (Visakhapatnam)
🏢 Pfizer
📍 Visakhapatnam