Well versed with Analytical methods validation/Method transfer/Cleaning validation, Handling HPLC, GC, DR and other instruments, Reviewing analytical data. Preparation of Validation protocols and reports.
Minimum 2 years' experience in analysis of FG/RM/Stability/ PM samples using various QC instruments (LCMS/HPLC/GC/Dissolution, Malvern 3000 etc). Exposure to LIMS preferred.
Candidate should be proficient in GLP. HPLC. GC, Instrumentation. Chemical Analysis, Raw Material Analysis, FG Analysis, UV. FTIR. In-Process Sample Analysis, and Stability Sample Analysis.
M.Pharm, B.Pharm, M.Sc ; Exposure to method validation, method transfer on various QC instruments LCMS, HPLC, GC, Dissolution, Malvern 3000 etc. Familiarity with protocol, report preparation.
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.
Candidate should have strong understanding of OSD manufacturing processes and knowledge of cGMP and relevant regulatory requirements. Monitoring critical process parameters during manufacturing. Candidate should have sound knowledge of QMS - Incidents, Change control, Deviations etc. Should be able to handle the team of 8-10 persons
Day-to-day production activities, Machine operation, GMP Compliance. Exposure to Topical products like; Cream, Lotion, Gel Manufacturing and packing and its documentation. Good Communication, Presentation and Man Management skills.
M. Pharma / B. Pharma; Awareness of regulatory requirement, ANDA filing & new Product filing application, Handle Field Alert Report, Market complaint, Review & presentation of Data, Tracking of data. Planning for sample pullout, Batch charging, storage & reconciliation, destruction & smooth functioning of Stability chamber, Walk-in Chamber