2-3

Manufacturing process like Autoclave, vial washing, filling ,Coating, compression ,capsule filling and packing. Microfluidizer equipment handled ,CIP,SIP system, Lyophilizer

Expertise in Nitrosamine and elemental impurities and recent regulatory updates. Handling of analytical instruments e.g. HPLC, UPLC, UV, KF, Particle Size, Dissolution, LCMS, GCMS, ICPMS and Zetasizer. Expertise in Analytical Method Development Assay/ RS/CU/ Dissolution and report writing.

To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. M.Sc / BPharm or any relevant degree

Hands on experience of CIP, SIP skid, Vessel Operations, Compounding, filtration and autoclave, filter integrity machine.  Exposure to Isolators, Lyophilizer, single use systems.

Exposure to OSD Manufacturing operations like Granulation, Compression, Pellet coating, Capsule filling, Primary Packing and Secondary Packing. Expertise in e-BPR and e-log will be added advantage. Experience in analysis of Solid Oral - FP, In-process or Stability samples. Experience of HPLC, UV spectrophotometer and Dissolution Tester operation. Experience of Analytical Method Validation/Transfer Solid Oral. Experience of GC, ICPMS and/or LCMS operation.

Reviews all Annual Product Quality Review APQR reports received from manufacturing partners and prepares APQR reports other than those received from the manufacturers within the prescribed time frame.

Collaborate with outsource parties to full fill laboratory requirement in timely manner. Previous experience in analytical method validation would be an added advantage.

Good exposure require in IPQA - Sterile, Qualification Sterile & OSD & Documentation Cell. Finished, AMV & Stability Section, knowledge of Instrument - HPLC. GC. Preferably know-how of Chromeleon Software.