3-4

Responsible for Execution of Placebo, Scale up & Trial batches. Review Validation protocol, Report, responsible for validation batches manufacturing. Preparation of scale up and trial batch summary to support the commercialization of products.

A Masters M.Pharm or M.Sc. or M.Tech. or M.E. or Bachelors B.Tech or B.E. or B.Pharm. An understanding of the Process Development and Industrial perspective of Biotherapeutics/ Biosimilars. Basic understanding of analytical techniques, statistical analysis, data management and analysis.

Experiences in HPLC, GC, LCMS, GCMS, IR, UV, Dissolution, Polarimeter, Potentiometric titrations, KF, PSD by Malvern and Other wet & Physical analysis

Preparation of Clinical Study Reports CSR for EMEA, WHO, SAHPRA. TGA, US- FDA, Costa Rica, others regulatory and Appendices and formats as per projects

Exposure of Waters HPLC, Dissolution, GC and other Instruments with AMV, RM, PM, FP product analysis Handling of QMS related Activities Exposure of various instruments/ software like Empower 3, LIMS and other softwares

M.Pharm, B.Pharm, M.Sc, B.Sc, ITI, Diploma. IPQA, Document Cell, Market Complaints, Market Recall, 00S, 00T, Process, Cleaning Validation, Review of BMR and BPR, Training ,QMS

Candidate should have knowledge of manufacturing operations of granulation, compression, coating and capsule filling, responsible to adherence cGMP guidelines. USFDA, MHRA exposure is must.

Aseptic & Controlled area operation. Ophthalmic, PFS, Cartridges, Lyophilizer and Vial, Bag Line, Robotic Line. Dyno Truking filling and sealing machine, Bosch filling machine, Steam sterilizer

Manage bulk bottle, blister packing, Track and Trace, serialization and documentation. Handle machines like CVC, Servo, Countec, CAM, BQS, HONGA & UHLMANN.