Deputy Manager Analytical Quality Assurance

Designation - Deputy Manager Analytical Quality Assurance Experience Required: 10 12 years Location: Atali Sr. No. | Job Description/Responsibilities | - | To review the Validation Master Plan, Site Master File, Drug Master File, Annual Product Quality Review, Plant Layout and other documents related to QA. | - | To review quality systems related documents e.g SOPs , vendor list, audit plan, audit schedule ,etc. | - | To approval COA of raw material, in-process, intermediate, packing material, finished products etc. | - | To review and approve of Quality Risk Assessment. | - | To issue the quality systems related documents e.g batch production records, analytical record, SOPs, logbooks, formats, specification, test protocols etc | - | To review, assess, and approve Quality Management System (QMS) documentation, including Change Control, Deviation, Out-of-Specification (OOS), Out-of-Trend (OOT), Market Complaint, Incident, Event, Returned Goods, and CAPA records | - | To review and approve laboratory incidents e.g out of specification (OOS), Incident, Event, Out of Trend (OOT), CAPA etc | - | To prepare and review investigating of deviation, market complaint, CAPA, change control etc. | - | To review and approve of quality systems related documents e.g. Batch production records, Process validation Protocol, qualification protocol & reports, Continuous Process Verification Report, Annual Product Quality Review etc. | - | To Review and approve Analytical Reports, calibration records and analyst qualification reports (AQ) etc. | - | To Handling of non-conformity as per defined procedure. | - | To Monitoring and ensuring the good laboratory practice (GLP) by laboratory personal during the routine analysis and instrument operation ensure adherence to procedure. | - | To Monitoring and ensuring the good manufacturing practice (GMP) at manufacturing site. | - | To schedule and provide training on quality-related procedures and regulations. | - | To conduct internal audit, raw/packing material vendor audit, service provider audit as per the schedule to ensure compliance. | - | To receive and store compiled/filled documents and update the respective register, wherever applicable. | - | To maintain quality documents and storage in a good condition. | - | To assign the batch for dispatch as per the customer requirement and plan the dispatch in coordination with production, stores and quality control. | - | To monitor the review activity for the in-process, intermediate, raw material, packing material, finished goods and water protocol along with the review of audit trail wherever applicable and lock the sequence. | - | To perform In-process Quality Assurance Rounds (IPQA) in Quality Control Lab. | - | To review schedules for instrument calibration, hold time study, stability study, etc. | - | To review the stability/ hold time study program and maintain the related documents. | - | To review the retention samples, record and maintain the related documents. | - | To Follow instruction given by Head of Department (HOD). | Interested candidate please send me your resume on rect3@saigroupbrd.com or whatsApp me on 8866075122 Total Work Experience: Current CTC: Expectation CTC: Current Company Name: Current Designation: Qualification: Notice Period: Current Location: Reason for job change: