Ahmedabad

B.Pharm / M.Pharm; Archival and life cycle management of the CTD, e-CTD submission. Senior Executive Regulatory Publishing eCTD

M.Pharm, B.Pharm, MSc ; Environmental Monitoring activities in a sterile/aseptic manufacturing facility. Conduct and supervise non-viable particle monitoring and line clearance operations.

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.

The ideal candidate should have a proven track record in method development for NCE molecules, a deep understanding of column chemistry used in HPLC, and significant experience with purification techniques. Responsibilities will include troubleshooting and calibration of analytical instruments, managing complex research projects, and ensuring timely, high-quality delivery.

Require young and skilled employees with experience in Parenteral / Injectable formulations for manufacturing facility at Ahmedabad, Gujarat in the following areas.

Inviting Hardworking and dedicated Candidates to be part of our team for our ongoing expansion of EU/LATAM/GCC/SEA regions.

To be responsible for Receipt, verification, storage and issuance of laboratory chemicals and glassware. To be responsible for Preparations of volumetric solutions, test solutions, limit test solutions and indicator solutions.

To ensure compliance of computerized systems, PLC, SCADA-controlled equipment, and automation systems with regulatory requirements 21 CFR Part 11, EU Annex 11, GAMP 5, etc. by executing validation activities as per approved procedures and maintaining validated states throughout the system lifecycle.

M.Pharm, B.Pharm, M.Sc, B.Sc ; QMS, Manufacturing, Ampoule Washing, Visual Inspection, Autoclave, Lyo, Filling & Sealing, Terminal Sterilization.