Quality Manager

4 weeks ago


Navi Mumbai, Maharashtra, India Vijaya Management Services Full time
Designation : QA ManagerLocation : MumbaiQualifications : Degree in a science-related field, chemistry or pharmacyExperience : 3+ years in R&D Pharmaceutical Industry from QA DepartmentResponsibility :* Review of Manufacturing Processes.* Knowledge of All regulated Guideline & Pharmacopoeia.* Preparation & implementation of SOPs related to the concerned department & Justification of Specification.* Nitrosamine Impurity, Elemental impurity, Genotoxic Impurity & their role related DMF Filing.* QA person collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications.* The QA person conducts regular internal audits of the manufacturing facility at R&D to ensure that the facility meets the required quality standards. Also handles the external audit cand its compliance.* QA person is responsible for ensuring that all necessary documentation is completed accurately, in a timely manner, and in compliance with regulatory requirements* The QA person is responsible for reviewing and approving deviation reports and ensuring that corrective and preventive actions (CAPA) are implemented.* The QA person is responsible for reviewing and investigating product complaints to ensure implementation of corrective and preventive actions (CAPA)* QA person is responsible for training of manufacturing and laboratory personnel on quality-related procedures and regulations.* Handling of out of specification (OOS) and out of trend (OOT) laboratory incidents and their closing.* Preparation & review the method of analysis (MOA), standard testing procedure (STP) and other documents related to QC.* Implementation & verification, in-process checks, online entries in BPR of product at Pilot plant manufacturing site.* Monitoring and ensuring the good manufacturing practice (GMP) at manufacturing site.Contact Person- Deepak - ID-
  • Experience3 - 8 Years
  • No. of Openings2
  • EducationDiploma, Professional Degree, B.Pharma, B.Sc, B.E, B.Tech, M.Sc
  • RoleQuality Manager
  • Industry TypeChemicals / PetroChemical / Plastic / Rubber / Glass / Paints
  • GenderMale
  • Job CountryIndia
  • Job TypeWork from Office

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