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3M Assistant Quality Assurance Manager India, Maharashtra, Pune 567964908
03.12.2024
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Job Description:
Strategic Planning:
· Prepare, update & ensure compliance to QA KPIs
· Provide project updates for new products from QA & QC perspective & lead QA/QC projects for process improvements
· Participate in the Plant meeting on different requirements & provide inputs as required
· Coordinate with QC to create departmental goals to align business goals & acheive targets on set deadlines
· Prepare departmental budgets & manpower planning to ensure smooth functioning of QC & QA.
· Ensure regulatory compliance as per State FDA.
· Keep abreast with current QMS & Regulatory requirements
· Ensure compliance during all kind of audits - Internal & External
· Prepare, update & ensure compliance to QA KPIs
· Provide project updates for new products from QA & QC perspective & lead QA/QC projects for process improvements
· Participate in the Plant meeting on different requirements & provide inputs as required
· Coordinate with QC to create departmental goals to align business goals & acheive targets on set deadlines
· Prepare departmental budgets & manpower planning to ensure smooth functioning of QC & QA.
· Ensure regulatory compliance as per State FDA.
· Keep abreast with current QMS & Regulatory requirements
· Ensure compliance during all kind of audits - Internal & External
Quality Assurance:
· Implementation of strngent Quality Management system & coordinate with cross function to ensure compliance at the plant. Assist in QMS implementation at the suppliers & warehouses at different locations.
· Conduct Quality assessment of changes(Change Management) to manufacturing processes, materials, design and procedures and ensure applicable and appropriate documentation
· Conduct internal audits, GMP rounds on shop floor & work with cross functional team on closure of gaps
· Review & lead Root cause analysis & CAPAs for GMP, Product & Process related issues & timely closures.
· Handle Customer Complaints, related investigations & closures in the management modules
· Conduct audits at the 3rd party vendors, suppliers & ensure compliances as per QMS & regulatory requirements
· Review BMRs & Validation documents for final release of products
· Thorough knowledge of Schedule M, WHO-GMP, GLP, GDP, ISO 13485:2016 requirements
· Implementation of strngent Quality Management system & coordinate with cross function to ensure compliance at the plant. Assist in QMS implementation at the suppliers & warehouses at different locations.
· Conduct Quality assessment of changes(Change Management) to manufacturing processes, materials, design and procedures and ensure applicable and appropriate documentation
· Conduct internal audits, GMP rounds on shop floor & work with cross functional team on closure of gaps
· Review & lead Root cause analysis & CAPAs for GMP, Product & Process related issues & timely closures.
· Handle Customer Complaints, related investigations & closures in the management modules
· Conduct audits at the 3rd party vendors, suppliers & ensure compliances as per QMS & regulatory requirements
· Review BMRs & Validation documents for final release of products
· Thorough knowledge of Schedule M, WHO-GMP, GLP, GDP, ISO 13485:2016 requirements
Regulatory :
· Coordinate with Reg. manager to ensure compliances & maintain annual license and registrations
· Assist with label requirement and review for compliance before release, must comply with D & C & LM requirements
· Coordinate with Reg. consultant for any regulatory requirements as & when required.
· Coordinate with Reg. manager to ensure compliances & maintain annual license and registrations
· Assist with label requirement and review for compliance before release, must comply with D & C & LM requirements
· Coordinate with Reg. consultant for any regulatory requirements as & when required.
Others:
· Assist QC for smooth operations on daily basis
· Assist government affairs for tender participation documents
· Coordinate with business on the various requirements with respect to QMS & assist with meeting the company goals
· Handling QA/QC team & their devlopment requirements
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
Please access the linked document by clicking select the country where you are applying for employment, and review. Before submitting your application, you will be asked to confirm your agreement with the terms.
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