Assistant Quality Assurance Manager

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