6 to 8 Years of experience in cGMP documentation of engineering in biopharma.
Should be Well versed with cGMP and regulatory compliance for engineering documentation. Responsible for Quality Management System documentation like Deviation, investigation, Change control, Corrective
Action and Preventive Actions.
Review and preparation of preventive maintenance Standard Operating Procedures with compliance for process and utilities Equipment’s.
Responsible for Documentation related to Preventive maintenance, Breakdown maintenance, Logbook entries shall be carried out in line with Standard Operating Procedures.
Responsible in Coordinating with team for Training and Development compliance.
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