Job
Description
JOB DESCRIPTION Department : Quality Control Chemical Designation : Manager – Stability Reporting To : Head – Quality Control Educational Qualification : M. Pharma / M.Sc. (Chemistry/Pharmaceutical Sciences) Job Responsibilities 1.Responsible for preparation and review of Stability Study Protocols, Stability Study Reports, and Stability Summary Sheets for all products (General Injectables and OSD). 2 Responsible for initiation, monitoring, and timely execution of stability studies for registration batches, validation batches, and commercial batches as per ICH guidelines. 3 Responsible for managing stability chambers, their qualification, calibration, and monitoring as per regulatory and internal guidelines. 4 Responsible for monitoring pull-out schedules, analysis of stability samples, and ensuring timely reporting. 5 Responsible for statistical analysis, trending, and evaluation of stability data, including identification and investigation of Out of Trend (OOT) and Out of Specification (OOS) results. 6 Responsible for preparation, review, and approval of analytical reports for Finished Products, In-process materials, Raw Materials, Packaging Materials, Water and Steam (Condensate) samples, including stability samples. 7 Responsible for preparation, review, and execution of Analytical Method Transfers and Method Validations related to stability and routine testing. 8 Responsible for preparation and review of Standard Operating Procedures (SOPs), Analytical Test Data Sheets, General Test Procedures, Specifications, and Calibration Data Sheets. 9 Responsible for review and handling of laboratory incidents, Out of Calibration (OOC) reports, deviations, OOS, OOE, OOT events, Change Controls, and Corrective and Preventive Actions (CAPA). 10 Responsible for Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) implementation and compliance across the team. 11 Responsible for preparation/review of Qualification Reports/Protocols for instruments and equipment used in the QC Laboratory. 12 Responsible for preventive maintenance schedules, calibration schedules, and management of instruments, including handling of breakdowns. 13 Responsible for management of Working Standards, Reference Standards, and Impurity Standards, including procurement, qualification, issuance, and maintenance. 14 Responsible for allocation of work, supervision, and review of activities performed by the QC team members and ensuring section-wise coordination. 15 Responsible for providing GMP/SOP/Analytical training to QC personnel and ensuring compliance to safety practices within the QC department. 16 Responsible for acting as Section Head and taking charge in the absence of the QC Head to ensure continuity and compliance. 17 Responsible for executing and monitoring QC activities related to the General block and Oncology block (ADL, R&D) at BDR Pharmaceuticals International Pvt Ltd, Baska Site. 18 Responsible for self-training and tracking of training status for self and team members on all applicable SOPs and protocols. 19 Responsible for cross-functional communication with R&D, QA, Production, and Regulatory Affairs teams for new product stability requirements, troubleshooting, and regulatory submissions. 20 Additional responsibilities shall be assigned as per organizational requirements based on operational needs.
