5+

M.Sc / B.Pharm / M.Pharm; Computerized System Validation CSV, MES, Equipment Qualification; RM/PM, Dispensing, Inspection

B.Pharmacy / M.Pharmacy; Candidate should have Injectable experience and sound knowledge on manufacturing and packing activities of liquid and Lyo products. Aseptic process simulation, process validation, cleaning validation, Batch records review and batch release.

Knowledge of FDA, cGMP, ICH, DMF guidelines for regulatory submissions. Hands on experience in CMC submissions, supplemental applications. Experience working on labels will have added advantage. Excellent written and verbal communication skills; experience in Regulatory Affairs of Finished dosage formulations mainly for USFDA, EU. M Pharmacy / M. Sc. / B Pharm

M.Pharm / B.Pharm / M. tech / B. tech / B.E. / B.sc / Diploma / ITI; Tablet, Capsule - Granulation, Compression, Coating, Inspection, Capsule Filling and Wurster coater. HPLC, GC, IR, UV, Dissolution and other QC Equipment, QC Method Validation and Transfer.

HPLC, GC, IC method development, Validation and Transfer for API, complex OSD, complex generics products like long acting injectables, nasal sprays, peptide injections, peptide OSDs, oncology and Topical products etc using various analytical technique. Expertly in peptide characterization. Well versed with USP/EP/BP/IP and various current regulatory guidelines ICH/ EMEA/ FDA Hands on experience on Nitrosamine and Genotoxic impurities method development, M.Pharm / M.Sc

Execute the production planning in Liquid manufacturing block and ensure the production plan achievement as per plan. Responsible to ensure the entry and exit, gowning and personnel hygiene procedures are followed in liquid manufacturing block.

In this role, the Senior Scientist-I will work on isolation, purification of known and unknown impurities, compounds by preparative HPLC and characterization of molecules using various analytical technique. Prepare, execute, and complete IQ/OQ/PQ of new instruments. Indent the required glass ware, chemicals, and columns for the ARD projects.

B.Sc/M.Sc/ B. Pharm/ M.Pharm with relevant experience. HPLC/ IP/ FP/ RM/ Validation/ Stability/ GC/ GLP; Hetero Drugs is an Indian pharmaceutical company and the worlds largest producer of anti-retroviral drugs. Heteros business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.

B.Sc / M.Sc / B.Pharma / M.Pharma; Review HPLC methods, chromatograms, and system suitability. Ensure HPLC sequences comply with methods. Prepare and review IQ, OQ, and PQ for new instruments. Conduct pre-investigations for OOS, OOC, OOT, and lab incidents. To perform line clearance, FG Sample withdrawal, Online GMP Monitoring, To Support of Product and Process Validation