2.0 - 7.0 years

2 - 7 Lacs

Bengaluru

Work from Office

Role & responsibilities: Perform commissioning & qualification and validation activities for biopharmaceutical manufacturing facilities in the BU. Responsible for timely preparation, review and approval of URS, DQ, IQ, OQ and PQ protocols, and reports along with operation staff and QA. Responsible for timely preparation, review and approval of other validation documents. Coordinate the Calibration Program, Preventive Maintenance Program and Alarm Management for the biopharmaceutical manufacturing facilities. Responsible for appropriate planning and timely execution along with review and approval of reports. Responsible for robust and optimal practices for maintenance and calibration program to upkeep the facilities. Responsible for establishment of appropriate Alarm Management system and implementation. Perform investigation for equipment failure to identify root cause and propose and implement appropriate CAPA to prevent reoccurrence. Participate in large & small capital projects; finalize conceptual design, basic design and detailed engineering design along with E&M team. Perform regular facility walkthroughs and internal audit for Manufacturing Plants and Operations Function to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessment. Perform Risk Management for Biologics Operations covering following elements and lead proposal and implementation of appropriate risk mitigation actions (CAPA). Quality and Compliance Risks Operational Risks of Data Integrity Risks • Perform and support timely preparation, review and approval of Standard Operating Procedures (EOP, IOP and SOP) and review of executed records. Preferred candidate profile: Engineering Commissioning & Qualification in Biopharmaceutical Industry.

Posted 2 months ago

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