"""• 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."""
