Quality Control Incharge

We are looking for QC - Manager profile with 15-20 years' experience in Quality Control of API Pharma. Specifically looking for candidates from Vizag or nearby locations.

• Responsible for all QC activities at OWN manufacturing site located at Vizag.
• Ensure timely completion of vendor samples, RM, In-process, cleaning samples, stability samples, FP analysis and miscellaneous samples.
• Plan and perform QC work such that production-related activities continue uninterrupted
• Identify training needs of QC personnel and provide job-related training to meet the GLP needs and skill upgradation.
• Maintain analytical instruments with suitable calibrations, preventive maintenance and supporting documentation.
• Plan and execute all validation activities for RM, in-process, finished products and related aspects such as method validations/verifications, stability studies and other related activities for existing and new products.
• Work closely with QA team for QMS-related activities for routine work and audits.
• Work closely transfers to all locations (own sites/CMO).
• Provide document support for DMF filings.
• Provide document support for new product license application with drugs control dept.
• Establish new methods at own lab and perform method demonstration/method transfer at customer-end.
• Actively participate in solving customer complaint/query related to analysis and to perform joint testing at own/customer lab, as required.
• Co-ordinate with external test lab for analysis and review of reports.
• Ensure timely testing of product as per customer specification.
• Ensure suitable samples, WS, raw data and test reports are shared with QA as per customer needs .
• Enable setting up of GLP at own site located at Vizag. This activity requires hiring of QC personnel and their training, improve SOP system, procurement of QC instruments and its qualification, support with documentation for drug license application, method transfers from R&D to plant (as applicable) and other GLP related activities.
• with R&D team for activities related to vendor approval, method improvements, method QC.