ASG Biochem Private Limited-QA/Regulatory Executive-Kolkata-k

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Careers Save this Job Report this job ASG Biochem Private Limited at Ganganagar near Kolkata, West Bengal, India, is a bulk API manufacturing company of the New Delhi based diversified APEEJAY STYA GROUP. The unit acquired from AKZO NOBEL N.V., the Netherlands in 2004 is engaged in the synthesis of specialized APIs, in particular, hormones and intermediates. Our world class manufacturing facilities have many laurels to its name not only for quality but also for research, production, productivity, safety and environmental standards. The unit has global exports including intermediates / penultimates to the European Union apart from supply to internal Group companies. In addition, the plant also holds ISO 9001-2008 and ISO 14001:2004 certification from DNV, the Netherlands. The company expects to achieve several key international regulatory approval for its APIs within a short period of time. Designation Qa/regulatory Executive Job Description Co-ordinate all activities related to external / internal audit / inspection. Conduct Inspection / Audit in connection with c-GMP / ISO 9001 : 2008 Review Batch Manufacturing Record, Certificate of Analysis of the Product. Conduct IPQA & activities in connection with Production Line Clearance. Review documents like DQ, IQ, OQ & PQ and documents related to Process Validation / Analytical Method Validation Prepare documents in connection with Drug Regulatory Affairs. Preparation of open / restricted part of DMF, CTD, ASMF, Technical Data Packages for Regulatory Affairs as per requirement. Desired Profile Post Graduate in Organic / Analytical Chemistry or in Pharmacy preferably having CTS (Competent Technical Staff Certification) from The Directorate of Drugs Control and knowledge of c-GMP as per Schedule-M, WHO- GMP ICH-Q7A & ISO 9001: 2008 Quality Management System. Exposure to the activities of Regulatory Affairs, c-GMP as per Schedule-M, WHO- GMP, Quality Management System Maintenance as per ISO 9001 : 2008 & Preparation of Drug Master File / Registration Dossier. Past experience of handling external audit, inspection by regulatory authorities. Experience 1 - 6 Years Industry Type Pharma / Biotech / Clinical Research Role Regulatory Affairs Manager Functional Area Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology Education UG - B.Sc - Chemistry PG - M.Sc - Chemistry DOCTORATE - Doctorate Not Required Compensation: As per industry norms Location Kolkata Keywords Regulatory Quality Assurance / TestingDrug Master Filingaudit regulatory affairs Contact Apeejay Stya House 14, Commercial Complex Masjid Moth, G. K. - II NEW DELHI,Delhi,India 110001 Website http://www.asgbiochem.com Job Posted 14 Sep Save this Job Report this job APPLY ONLINE