Torrent Pharma

HPLC, GC, IC method development, feasibility, verification, equivalency, validation for API, complex OSD products, oncology products, topical products having exposure to regulated, Semi Regulated & India markets

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

To monitor the Demo, Scale up, exhibit, and launch batches. To take scale up batch, Exhibit batches and work on Trouble shooting. To perform investigation for Deviation/ OOS/ OOT observed at plant.

M.Sc. / M.Pharm, Technically competent on analytical method development and Validation of complex products like liposomes, transdermal, long acting injectable, suspensions, Nano particles, Microspheres, topicals and peptides. Responsible for developing, establishing, and validating analytical testing methodologies, transfer; ensure all analytical testing activities are in compliance with applicable regulatory guidance. 

Formulation development of Injectable including development, execution, filing and approval of Complex Injectables viz. Liposomes, Peptides, long acting emulsions, suspensions, in-situ gels, Lyophilised injectable etc.

M.Sc / B.Pharm / M.Pharm. Material Dispensing, Ointment, Gel Manufacturing, Filling, Packing, Track and Trace, Labelling, Cartonator, QMS. IPQA, Document Cell, OOS, OOT, Process/ Cleaning Validation, Review of BMR & BPR, Training ,QMS Investigation, CAPA, SOPs etc.

HPLC, GC method development for OSD & API having exposure to regulated, Semi Regulated and India markets including Complex generic, F2F, Topical and Dermaceuticals, Peptides, Oncology.

Knowledge of Documentation, QMS, Deviation, Change Control, Market Complaint, OOS, OOT, Validation Qualification, IPQA, Audit Compliance.

Ensure the on-time filing of high-quality regulatory submission, and to assist in the preparation, maintenance, and control of regulatory dossiers. Interact with Regulatory agency on regulatory submissions and follow up for drug product approvals.