QA

Ensures that justified extension requests are made before the investigation deadline and that the investigations and CAPAs are closed within the required timeframe. Acts as a guardian of metrics by carrying out periodic follow-ups regarding investigations and CAPAs opened with internal and external partners. 

Assist in developing global Pharmacovigilance system auditing program and responsible for conducting and reporting audits being a lead auditor, co-auditor for outsourced parties CROs, Service Providers, Vendors, Affiliates & Partners etc., associated with Sun Pharma

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

Ensure that Bulk Viral Antigen production adheres to GMP standards on the shop floor, including line clearance, dispensing, and preparation processes. Examining and approving batch records, standard operating procedures, project plans, customer verification, and APS documents.

Facility located at Vadodara, Gujarat Location and has been designed to support scale up and commercial supply of Injectable Formulations.

SCIENCES OR PHARMACY GRADUATES B.SC, M.SC, B. PHARM, M. PHARM WITH 0 TO 5 YEARS EXPERIENCES IN PARENTERAL MANUFACTURING VIAL, AMPOULES, BOTTLES OF GLASS OR PLASTIC THROUGH, LVP/SVP WITH BFS TECHNOLOGY. CANDIDATE WORKED IN PRODUCTION COMPLIANCES, REMEDIATION AND HAVING EXPERIENCES OF MANAGING QUALITY SYSTEM DOCUMENT

Responsible for QMS Team lead for Block, Exposure to US, EU and CA regulatory requirements, Handling of market complaint

Emcure is fast-growing Indian pharmaceutical company engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products globally.

Having Experience in PRODUCT, Water Testing, In process Sampling, Analysis of Bulk Water, Finished and API by MLT, Bioburden, BET, Sterility, PET and Antibiotic Assay.