Vacancy For Executive / Manager - Analytical QA and Executive - IPQA Dishman Carbogen Amcis

5.0 - 10.0 years

5 - 10 Lacs

ahmedabad

Work from Office

Role & responsibilities Analytical QA Review the analytical documents which are generated after analysis of Drug Products. Preparation and Review of all Departmental SOP's for cGMP Compliance. Compilation and Review of the Batch Records, Certificate of Analysis, Analytical Protocol, etc which are required for release of Batches. Review and Approve SOPs, Change Controls, Deviations, Annual Product Quality Reviews, Incident Reports, Out of Calibrations, Out of Specifications, Out of Trends, Approve the Investigation Reports. Market Compliant, & manage Stability Samples etc. Review of Regulatory Requirements and its Compliance. Periodic review of all Quality functions and Procedure for appropriateness and review of related documents. Responsible for all SAP, LIMS, ERP etc. transactions related to release, reject or block or unblock or raw material, packaging material, in process product and finished product. To provide Final Decision and check Tracking, implementation and effectiveness of Corrective and Preventive Action (CAPA). IPQA To perform In Process Quality Assurance (IPQA) activities to ensure cGMP compliance following the approved SOPs. To check and certify line clearance. To ensure Cleanliness for the GMP areas. To perform in-process sampling and testing. To ensure timely record of the data and proper arrangements of documents. Review of Batch Manufacturing Records/ECR/Analytical Documents. Sampling of Finished Product and its respective records.Ensure that compliance with existing SOPs, cGMP/cGLP. Perform other work allocated by designated person. A person should be having knowledge about the current guideline. Preferred candidate profile The Candidate should have Current or Previous Experience in Bulk Drugs / API.

Posted 1 week ago

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