Company Jobs

Supervision of aseptic area activities, shift handling, aseptic area documentation, media fill activities, aseptic behaviour monitoring, and sterile operations. Handling area cleaning and sanitation activities, supervising steam sterilizer loads, filter integrity, disinfectant preparation and filtration activity, and related documents.

M.Pharm / M. Sc; Perform and review method validation of Assay, Dissolution, Related compound and Residual solvents etc. for new projects using instruments like HPLC,UV, IC ,GC,ICP MS and AAS etc. Preparation of method validation/verification protocol (API and finish product) like HPLC, GC, IC, and AAS etc.

Design, plan and perform scientific experiments for projects at different clinical phases of drug substance and drug product with minimal guidance. Well versed with regulatory guidelines, scientific literature, technology transfer and interpretation of the results to draw conclusions in reports.

Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA, Food and Drug Administration and EMA, European Medicines Agency, and SOPs/ QDs. Review study team-developed documents as per SOP, such as study id card, protocol, amendments, WSI, eCRF Case Report Form and completion guidelines, Centralized Monitoring Plan, committee charters and or other operational documents as requested to provide operational input.

B.Sc. / B.Pharma / B.Tech. Food; Tirupati Group is contract manufacturer of Pharmaceuticals, Nutraceuticals, Ayurveda & Sports Nutrition products.

B.Sc./ B. Pharmacy /M.Sc. M. Pharmacy; Preparation and review of Standard operating procedures Retrieval of BPCRs in case of batch cancellation, planning changes. Handling and Execution and investigation of QMS documents in change controls, deviations, and CAPA.

M.Sc. / B. Pharm / M. Pharm. Review of Electronic data on various QC instrument Like HPLC, GC, FTIR, UV-Visible Spectrophotometer, TOC analyzer etc. Details experience on Audit Trail review of All QC instruments. Hands on Experience on Various QC instrument calibration like HPLC, GC, FTIR, Polarimeter, UV-Visible Spectrophotometer, Dissolution etc. Experience on Handling of OOS, OOT, OOC, Laboratory Incident investigation, Deviation etc.

B. Pharm, M. Pharm, B.E, B.Tech. with relevant experience in handling operations of packing line machine i.e. Plunger insertion cum labeling, vial labeling, Blister, Catenator, Track & Trace. experience supervising and controlling production areas like Aseptic Filling, Vial Washing, Autoclave and Lyophilizer. Exposure of machine qualification activity will be added advantage.

Require good knowledge in Complex Skid, NDDS, Aseptic PFS, Vials Liquid, Autoclave, Lyo, Batch Manufacturing Clean Area.