Senior Quality Assurance Executive at Dombivli.

Job Description

Urgent job opening for Senior Quality Assurance Executive at Dombivli. Qualification : B.Sc., M.Sc. Experience : 6 to 8 years Description of Job Responsibilities 1) Responsible for Preparation and review of master documents of QA department and review of all master documents and formats of respective departments other than QA. 2) Responsible for review of technical documents such as Technology Transfer, MPCR, BPCR, Specification and Standard test procedure, stability data, etc. 3) Responsible for preparation of training schedule and provide training on QA-related topics, guidelines, regulatory and cGMP requirements to all concerned employees. 4) To evaluate Quality and stability of finished APIs. 5) Responsible for organizing and execution of internal audit program, review of observations, follow ups and closures. 6) To investigate & approve Deviations, Out of Specification 7) Responsible for preparation, review of MSDS and approval 8) Responsible for preparation, review & approval of annual product quality review. 9) Responsible for providing effective CAPA procedures, tracking completion and implementation of the same. 10) Responsible for validation activities as per validation master plan 11) Responsible to investigate & approve customer complaints and provide responses to customers regarding complaints. 12) Ensure handling, effectiveness and continuous improvement of the QMS System. 13) Initiates Follow-Up Audit activities in order to verify Audits and record the implementation and effectiveness of the Corrections & Corrective Actions 14) To organize & performed vendor audits for critical raw materials/ packing materials & testing labs. 15) Initiates Follow-Up Audit activities in order to verify Audits and record the implementation and effectiveness of the Corrections & Corrective Actions 16) Responsible for updating and maintaining Quality management system documents 17) To ensure that the preparation, submission of Drug Master Files to customers/ authorities 18) To ensure that responsible & provide the audit compliances, DMF query responses, market complaints/ queries related to documents or products 19) To organize and participate in MRMs and to monitor actions of the same 20) Responsible for procedures of approval/rejection/release/dispatch for commercial batches and documents. 21) Responsible for the preparation DMF (Close & Open part), replying to the QA / RA related queries of Marketing, Exports, Customers, Regulatory authorities & all work related to Regulatory Affairs (RA) functions. 22) Responsible for maintaining and handling of vendor qualification activities. If you are interested for the above referred position, kindly revert back with your Updated Resume with Photograph along with following details: 1) Current salary 2) Expected salary 3) Notice period 4) Total experience 5) Relevant experience 6) Current location 7) Reason for job change Contact no.:- Sakshi - 8591939527 Mail ID:- sakshi@jobsearchindia.in