We having excellent job opening with leading Pharma industry for the post of “Manager- International Business Development",
Job Location: Changodar, Dist : Ahmedabad,.
Designation: GM - Quality
Department- QA- Pharmaceutical Formulation (Small Volume Parenteral, Lyophilised products, Oral Solids, Dry Powder Injections)
Education: B.Pharm. B.sc, M.Pharm., M.Sc.,
Experience: 15 Years
· Ensuring compliance to cGMP, GDP for plant operations
· Review and compare global quality policies, procedures and directives and regulatory guidelines with site procedures. Identify gaps and ensure inundation of site procedures.
· Successfully managed Regulated and Semi-regulated market audits
· Drive team to productivity and reduce attrition rate; capable of sourcing candidates for own team in minimum timeline
· Tracking and investigations of OOS / OOT from
manufacturing site on timely manner
· Checking compliance of response given to regulatory observation and queries
· Review and approve standard operating procedures, specification, master plans, standard testing procedure, protocols and reports
· Coordination with manufacturing, purchase, regulatory and R&D for smooth and timely execution of exhibit and commercial batches and new product launches.
· Review and completion of change controls of products, process, test method, equipment and facilities.
· Respond to inspection observation and business affiliate queries. Provide updates to regulatory agencies on compliance to response.
· Drive internal audit, ensure compliance to schedule and timely CAPA implementation.
· Approve risk management protocols and reports pertaining to various quality systems
· Organize and lead team to execute timely batch processing through validation and checks
· Manage and respond to market complaints adequately
|Experience||14 - 20 Years|
|Salary||8 Lac 50 Thousand To 13 Lac P.A.|
|Industry||Manufacturing / Production / Quality|
|Qualification||B.Pharma, B.Sc, M.Pharma|
|Key Skills||Qa Tester Qa Analyst Quality Asurance Quality improvement Quality maintenance|
|About Company||About Company - Leading manufacturing of Pharmaceutical products providing Liquid Orals, Cephalosporin Tablet, Capsule, Dry Powder Syrup, Dry Powder Injections, Liquid Injectables (SVP) in Ampoules and Vials & Lyophilized Injections. Currently serving into 38 countries across Asia. Countries Uganda, Kenya, Yemen, Ethiopia, Congo, Ghana, Zimbabwe(MCAZ), Cambodia, Vietnam, Malawi, Namibia, Nigeria, Cote d’ivoire, Philippines, Peru, Srilanka, Philippines, Vietnam, Cambodia, Sudan, Myanmar, Mauritius, and Costa Rica, Panama, El-salvador, Paraguay, etc|