Deputy Manager

Major purpose of the job :
• 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.• To coordinate and ensure execution of validation/qualification activitiesPrincipal Tasks and Responsibilities: Ensure timely release of Drug Substance (Bulks) manufactured in Biotech Division Managing, mentoring and tracking activities of team, Troubleshooting of key issues and reporting to HOD and management Managing External as well as Internal Audit and Audit compliance related activities Ensure Training index/training needs and completion of Team Ensure timely revision of all QA related SOP and follow up of same of different department SOP Ensure documentation management control as per SOP QA coordinator in TIMS to upload SOPs and training questioners1. Review, Approval of documents: SOP’s, Specification(s), STP’s , MMD’s, Batch Manufacturing Records, Technology Transfer Documents, analytical data, method validation, stability protocols and internal reference stranded qualification Change controls, incident, deviations, investigation report, Audit Compliance, Risk Assessment, shutdown, CAPA plan and its Effectiveness Equipment qualification/Process validation/ cleaning validation/hold time study protocol and reports2. Coordination and Execution: To Ensure execution of validation activities pertaining to:- Qualification of new equipments and Utilities (such as Water System, HVAC System, Pure Steam, Compressed Air)- Periodic re-qualification of existing equipments and critical systems- Area Qualification Coordination for execution of CAPA plan/risk mitigation plan and to ensure implementation of corrective and preventive action Coordination for tracking interdepartmental activities To supervise Execution of planner pertaining to qualification/validation and / preventive maintenance activities as per established schedule Coordination and Execution of self inspection plan Coordination with personnel from Pharma; manufacturing of sterile parental and QA for formulation and fill finish of biotechnological Drug Product (DP) Coordinate for Technology Transfer activities Coordinate for RM vendor qualification activity3. Review/Approval: Site Master file, Validation master plan, Halal manual and Quality management system manual To participate in cross functional activities as defined by HOD QA from time to time Any other job assigned by immediate superior/HOD from time to time