J V S Shankar

1.Responsible for the overall implementation and compliance of Quality management system. 2.To ensure continuous compliance of Quality system. 3.Product & cleaning Validations 4.Equipment qualifications 5.Investigations 6.Risk assessments etc 7. Site compliance 8.Training 9. Data Analytics

Can contribute as a Subject matter expert of -overall implementation and compliance of Quality management system. - to suggest methods ensure continuous compliance of Quality system. - Product & cleaning Validations -Equipment qualifications - Quality Investigations -Risk assessments - Site compliance -Training -To Create a new strong QMS platform in a growing organisation. -Regulatory exposures for the USFDA,EU, ANVISA & other audits for ROW countries. - Compliances to the regulatory audit observations - Preparing the plants for the regulatory business audits

1.Responsible for the overall implementation and compliance of Quality management system. 2.To ensure continuous compliance of Quality system. 3.Product & cleaning Validations 4.Equipment qualifications 5.Investigations 6.Risk assessments etc 7. Site compliance 8.Training 9. Data Analytics -Created a QMS platform in a growing organisation and lead the plant from the front during the USFDA audit in April 2024. On a time bound basis compliance to the 483s were submitted to FDA as per commitments and the plant received the EIR successfully indicating the closure of the inspection. -Currently work is under progress to get the plant approved for the EU regulations.

-Responsible for both the QA & QC functions of the plant to create and maintain a sustained Quality system. Lead the Quality team from the front for the preparations of TGA, Australia and successfully got the Plant certified for the TGA,Australia certification. -Responsible for the overall maintenance of Quality system - To Ensure the site is maintained in continuous state of compliance -Prepared the site for the EU GMP compliance.

Was responsible for the following activities 1.IPQA activities 2.Validation & Qualification activities 3.QMS activities 4.Investigations of OOS/OOT,deviations & customer complaints 5.Risk assessments 6.Finished Product release 7. Site compliance

Handled all the functions of QA i.e IPQA, PQR, Validations & Qualifications & QMS system including Lab-QA over the tenure of working.

Handled all the functions of QA i.e IPQA, PQR, Validations & Qualifications & QMS system including Lab-QA over the tenure of working.

Handled all the functions of QA i.e IPQA, PQR, Validations & Qualifications & QMS system and was Site Head-QA over the tenure of working.

Handled all the functions of QA i.e IPQA, PQR, Validations & Qualifications & QMS system including Lab-QA over the tenure of working.