QA

Subject Matter Expert for Drug-Device Combination Products will serve as a key resource within the organization for technical expertise and regulatory guidance related to the development, manufacturing, and commercialization of drug-device combination products.

B. Pharm , M.Sc. , M. Pharm with 2-8 years of relevant experience in IPQA , validation , Documentation related activities in Oral Solid,Oral Liquid,Semi Solid dosages manufacturing facilities.

Bachelors or Masters in Pharmacy. Must have exposure in handling of Process Area maintenance like Manufacturing Vassals, Filling machine, Autoclave, Isolators and Lyophilization.

BPharm or MPharm require; Review of Protocols and reports related to Analytical method validation, Verification of API and Finished product, Vendor qualification, cleaning validations. Hypothesis analysis, general validations, Stability, photo stability, thermal cycling, in use, split study and miscellaneous studies and approval in LIAAS where ever applicable.

M.Pharmacy/M.Sc Chemistry B.Pharmacy; Having injectable experience of Shop floor Supervising Activities like Component Preparation, Aseptic Filling, Compounding Operations, BMR Review and QMS Exposure.

M.Pharm, B.Pharm, M.Sc, B.Sc; Chemist and Analysts, Microbiologists, Validation; GLP Section -SPEC/STP Preparation, LIMS Documentation

Experience in Documentation, Issuance, CCF, Trackwise, SOP preparation, well versed with GMP and Regulatory requirements of USFDA, EU, ANVISA, AQA.

Handling HPLC, UPLC and GC. Knowledge in handling empower 3 software. Experience from Regulatory approved Sites are preferred.