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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
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
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.
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
Learn more about 3M's creative solutions to the world's problems at www.3M.com or on Twitter @3M.
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.
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