Job
Description
PRODUCTION BULK MANUFACTURING (DRUG SUBSTANCE / ANTIGENS) Designation: Assistant Manager/ Sr. Executive/Executive/Sr. Officer/Officer Qualification: M.Sc. (Lifesciences) / B. Pharmacy / Diploma / B.Sc. / ITI Desired Experience: Applicants with relevant experience in Vaccine, Biosimilars or Injectable Manufacturing will be considered. To perform Upstream and Downstream activities of bacterial or Viral antigens Execution of upstream and Downstream production batches. Focus on timely execution, to ensure that the process is carried out as per cGMP compliance and batch timelines Execution of documentation activities of liaison with QA and QC as per cGMP compliance. PRODUCTION FORMULATIONS (Injectables) Designation: Sr. Executive/Executive/Sr. Officer/Officer Qualification: M.Sc. (Lifesciences) / B. Pharmacy / Diploma / B.Sc. / ITI BLENDING: Ability to handle shift plans for formulation activities. Operate and maintain equipment like autoclave, blending vessels. Ability to handle and maintain equipment like autoclave, blending vessels, CIP and SIP skids. FILLING: Ability to handle shift plans for filling activities. Operate and maintain equipment like Vial washing, Tunnel Sterilizer, Filling and Capping. PACKING & LABELING: Ability to handle shift plans for Vial labeling Machine & VVM dot Machines with Inspection system. Operation of Videojet and Control print Printer for Batch Coding. Operation of Track & Trace System, monitoring of Cold room and Deep freezers temperatures. Engineering (Biologic/Injectables): Designation: Sr. Executive/ Executive/Sr. Officer/Officer Qualification: B Tech / Diploma Process Equipment's: Experience in Breakdowns and preventive maintenance of Vial Washing, Filling, Capping, Autoclave and Labelling Machines, Jacketed Vessels, lyophilization, Ability to handle shift operations. Instrumentation: Ability to handle shift operations for Instrumentation activities like BMS, Breakdown maintenance, Preventive Maintenance, Calibration, AMC and Interim projects, Reviewing the completion of breakdown status / Calibration / PM works, Handling basic troubleshooting in PLC (Programmable Logic Controllers) and SCADA (Supervisory Control & Data Acquisition). Quality Control (Biologics/Vaccines): Designation: Asst. Manager/Sr. Executive/Executive Qualification: M.Sc. (Lifesciences) / B. Tech/M. Tech (Biotechnology) Job Roles: Biochemical Assays: - Involved in the estimation of total and free components in polysaccharides, along with biochemical analyses such as protein, nucleic acid, aluminium content, and composition analysis. Experience in analytical method validation, adherence to ALCOA principles, and management of OOS and OOT investigations. Instrumentation Testing: - Hands-on experience in handling analytical instruments such as HPLC and IC, along with performing instrument-based assays including molecular size, aggregates, purity, and composition analysis. Basic troubleshooting, 21 CFR Part 11 and Audit trial review practices, ALCOA principles, OOS, OOT systems and investigations. Virology: Experience in in-vitro viral testing of Starting material, Raw material, In-process, Final bulk, Final lot and Stability samples for Viral vaccines. review testing for QC release of products/RM/stability studies of Viral Vaccines/New projects/Products QA In Process Designation: Deputy Manager / Asst. Manager/Sr. Executive/Executive Qualification: M. Pharmacy/M.Sc./ B. Pharmacy Drug Substance: To execute IPQA activities for Bulk Viral Antigen production, including ensuring GMP compliance on the shop floor, line clearance, dispensing, and preparation processes. review and approval of batch records, SOPs, PV, CV, and APS documents; QMS management; trending and batch release activities; control and reconciliation of Master and Working Cell Banks Drug Product: To execute IPQA Fill-Finish activities. including the review of SOPs, batch records, executed validations and media fills; line clearance for formulation and filling operations; and the management of change controls, deviations, OOS investigations, and trend analysis. QMS: Oversight of QMS activities, including change control, deviations, OOS, OOT, CAPA, and self-inspections, as well as conducting compliance walkthroughs and Gemba walks. Responsibilities also include trending and review of QMS metrics, support for regulatory inspection management, and the management of the Site Master File, gap assessments, and quality risk assessments.
