Assistant Manager

To ensure compliance of procedure and practices in line with GMP guidelines and regulatory expectations for concerned manufacturing facilities and products of Biotech division, Cadila Pharmaceuticals Ltd. . Review and release of Batches of API (Drug substance of STR, VLP, BOT, GCSF, EPO and IMM) including intermediate stages of production, In-process quality assurance checks, Area clearance for scheduled manufacturing activities and day to day compliance for manufacturing facilities during batch manufacturing activity. Review BMR related ROA for Release of Drug Substance (Bulks) manufactured in Biotech Division (STR, VLP, BOT, GCSF, EPO and IMM) Cell Bank management, such as issuance, trending monitoring and reconciliation. Coordinate and execute stability sampling as per requirement. Coordination for execution of CAPA plan/risk mitigation plan, QA Oversight GLP and Self inspection plan Annual Product Quality Review (APQR) reports of all products manufactured at CPL biotech facility. Training index/training needs identified by QA and other departments. Review and accountability for stability trend summary reports of DS and DP of STR, EPO, GCSF, and IMM. Prepare trend and conclusion report at and of stability. To prepare and review the summary lot protocol and submit the vaccine samples to CDL Kasauli with all supporting documents timely. Self Inspection Plan and QA Oversight. To actively investigate issues pertaining to Data Integrity as Management personnel To participate in cross functional activities as defined by HOD QA from time to time. To ensure and verify GMP and GLP checks in QC and Manufacturing area of Biotech division. Any other activity assigned by immediate supervisor/HOD or designee.