QC

Review of approved vendor list in-line with submitted, current DMF. Review of Raw materials, Packing materials specification and analytical procedures. Preparation of ODMF, Technical package as per customer requirement.

Review of BPR, batch cleaning record, test data sheet, Sampling of API finished goods. Preparation of APQR. Handing of QMS document Change control, Deviation, CAPA, OOS, OOT review.

Expertise of Finish goods testing, Stability, RM Testing, Analytical Method Validation, Dissolution, HPLC, PMQC, and knowledge of handle other sophisticated instruments like GC, XRD, ICPMS, LCMS.

Analytical Method development & Validation. Routine Analysis. IPQA, QMS, Analytical QA, R&D Complances

Having exposure related Environment Monitoring in formulation, water analysis, various Microbiological test like sterility, BET, MLT etc. Having exposure related to regulatory plant and basic know of GLP GMP. Ready to work in rotational shift.

Should have experience on HPLC (Agilent) Analysis & Wet Chemistry Analysis. HPLC Agilent - Trouble Shooting, Analysis & CGLP Knowledge.

Experiences in HPLC, GC, LCMS, GCMS, IR, UV, Dissolution, Polarimeter, Potentiometric titrations, KF, PSD by Malvern and Other wet & Physical analysis

Exposure of Waters HPLC, Dissolution, GC and other Instruments with AMV, RM, PM, FP product analysis Handling of QMS related Activities Exposure of various instruments/ software like Empower 3, LIMS and other softwares

Candidate should have knowledge of manufacturing operations of granulation, compression, coating and capsule filling, responsible to adherence cGMP guidelines. USFDA, MHRA exposure is must.