Ahmedabad

Supervise and lead the team of analytical development, Analytical method validation, technology transfer, forced degradation study, preformulation study, dissolution studies, Extractable and Leachable and technical query handling. Candidates must have exposure of Pharma regulatory approved organisations USFDA, MHRA, Eu and other Major regulatory bodies

Lead and mentor a team of research scientists and chemists. Oversee projects, ensuring timely, budget-friendly, and high-quality delivery. Provide expertise in solving complex synthetic challenges and optimising reactions

Analytical Method Development, Validation, Transfer activities of test like Assay, RS, Dissolution and Solvent. Calibration of the Analytical instruments like HPLC, GCHS, IR, UV & Disso as per the master calibration schedule. Carry out routine analysis & Ensure documents pertaining to day to day analysis.

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.

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.

Expected B.Pharm, M.Pharm, M.Sc, B.Sc by education with 2 plus years experience in Vial, Ampoule, Sterilizer, Tunnel and Washing, Component GMP wash and dry, Filling & Sealing area and Documentation

SCIENCES, PHARMACY GRADUATES B.SC, M.SC, B. PHARM, M. PHARM WITH 0 TO 3 YEARS EXPERIENCES IN ANY OF QA FUNCTION VALIDATION, IPQA, QMS, COMPLIANCE, DQA, LAB QA OF A FORMULATION - STERILE, NON STERILE DOSAGE

B.Pharma / M.Pharma/ B.Sc / M.Sc. (Organic Chemistry / Analytical Chemistry); experience in injectable manufacturing, Aseptic area operations, Packing, Visual inspection, QMS activities. relevant functional experience in OSD manufacturing and Packing operations / QMS activities

Analytical method validation of different methodology. Dissolution Method Development and validation. Validation and method development protocol and report preparation.