Torrent Pharma

M.Pharm / M.Sc; HPLC, GC, LC method development, feasibility, verification, equivalency, validation of API for complex OSD products, oncology products, topical product

Responsible to handle the team to achieve the set targets in Packaging area & maintain qualitative, quantitative as well as CGMP aspects. Knowledge of Dispensing, Sampling, Material Receiving & Issuance, SAP, Documentation.

Audit Response writing skill, Audit handling skill. Current Guideline assessment and compliance. Gap Assessment to overall Regulatory Compliance. Proficient in risk assessment, cleaning procedure optimization. Adept at collaborating with cross-functional teams to maintain robust cleaning validation programs.

Expertise in designing, executing, and reviewing cleaning validation protocols. ensuring compliance with cGMP. EMA. and other global regulatory requirements. Specializing in stability studies, regulatory compliance, and quality assurance oversight. Managing stability programs in alignment with ICH guidelines

Topical Formulation, Semi Solid Manufacturing, Cream Ointment Gel Production, QMS, SAP, In Process Checks, Deviation Handling and CAPA, Audit readiness and documentation, Production Planning and Scheduling, Cross functional collaboration, Team Supervision, Process Optimization.

HPLC, GC, Physical and Chemical Analysis, QMS,RM,PM. Material Dispensing, RM Store, FG Store, Environment Monitoring, SAP, Inventory, QMS

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.