Yogesh Somaiya Email & Phone Number

Ahmedabad, Gujarat, India

• Lead a team for Quality Compliance and Vendor management system.• Responsible for maintaining Vendor Qualification of Raw materials, Packaging Materials, Contract Laboratories, CRO and contract service providers.• To schedule and perform Physical On-site audit of API/FP Manufacturer and CROs located in India and follow up for CAPA. • Monitoring of BA/BE study at CRO, Review of Trial Master File, CRF and clinical study report. • Review and approval of Quality Agreement with supplier / Manufacturer of RM, PM and contract Lab. • Review of commercial batch manufacturing and packaging record for batch release. • Review and approval of Annual Product quality review. • Review and approval of Process Validation report. • Provide Monthly progress report to Director, Quality Compliance (USA). • To maintain cGMP and Quality compliance and Lead QA functions for R&D site.• Review and approval of Technology Transfer documents from FD and ADL Department for ANDA product submission.

Ahmedabad, Gujarat, India

• Lead a team for Quality Compliance and Vendor management system.• Responsible for maintaining Vendor Qualification of Raw materials, Packaging Materials, Contract Laboratories, CRO and contract service providers.• To schedule and perform Physical On-site audit of API/FP Manufacturer and CROs located in India and follow up for CAPA. • Monitoring of BA/BE study at CRO, Review of Trial Master File, CRF and clinical study report. • Review and approval of Quality Agreement with supplier / Manufacturer of RM, PM and contract Lab. • Review of commercial batch manufacturing and packaging record for batch release. • Review and approval of Annual Product quality review. • Review and approval of Process Validation report. • Provide Monthly progress report to Director, Quality Compliance (USA). • To maintain cGMP and Quality compliance and Lead QA functions for R&D site.• Review and approval of Technology Transfer documents from FD and ADL Department for ANDA product submission.

Ahmedabad, Gujarat, India

• Responsible for maintaining Vendor Qualification of Raw materials and Packaging Materials. • To schedule and perform Physical On-site audit of API/FP Manufacturer and CROs located in India and follow up for CAPA. • Monitoring of BA/BE study at CRO, Review of Trial Master File, CRF and clinical study report. • Review of commercial batch manufacturing and packaging record for batch release. • Review and approval of Annual Product quality review. • Review and approval of Process Validation report. • Provide Monthly progress report to Director, Quality Compliance (USA). • To maintain cGMP and Quality compliance and Lead QA functions for R&D site.• Review and approval of Technology Transfer documents from FD and ADL Department for ANDA product submission.

Ahmedabad, Gujarat, India

• To maintain cGMP and Quality compliance and Lead QA functions for R&D site.• Review and approval of Technology Transfer documents from FD and ADL Department for ANDA product submission.

Ahmedabad, Gujarat, India

• Lead a team of highly professional resources for Audit compliance and quality management system. • Responsible for Management of change control, deviation, Internal audit procedure at site. • Management of Regulatory and Customer audits and preparation of Audit compliance report.• Internal Audit: To schedule and organize GMP, GDP and Aseptic practices Internal Audit. Co-ordination and participation in the internal audits, review audit compliance and CAPA and closure report.• To review investigation generated from deviations, Market complaint, ADE, Out of Specification (OOS), OOT (Out of Trend) and Out of Calibration.• To perform risk assessment related to Facility, utility and Quality Management system.

Ahmedabad, Gujarat

Ahmedabad

• Responsible for review and approval of Qualification protocol and reports for Area, Equipment and utility systems.• To monitor and execute the equipment and utility qualification activity.• To perform Re-qualification of area and Equipment as per VMP schedule. • To prepare the Quality Risk management for the equipment.

Ahmedabad, Gujarat, India

• Preparation and Review of the Product Quality Review (PQRs) / Annual Product Review. • Investigation of the market complaints related to Adverse Drug Events (ADEs).• Review of Master / Executed batch documents. i.e. MPCRs and BPCRs for batch release. • Coordination and Monitoring of the Training for the Quality Assurance Department.• To handle the query related to BMRs and APRs from customer.

Kandla Gujarat

• Responsible for IPQA activities. (Tablets, capsules and Dry syrup).• Preparation of process validation protocol, execution of the validation and compilation of reports.• Monitoring of stability study and management & Periodic Inspection of retain Samples.• Coordination of the QMS activities i.e. change control proposal, deviation and incident reports.• CAPA & follow up for compliance of NCR.• Maintain Vendor related documents at site.

B.Pharma, Pharmaceuticals

Hsc, High School/Secondary Diplomas And Certificates