Shiv Gupta Email & Phone Number

Maastricht, LI, NL

Reykjavík, Capital Region, Iceland

 Responsible for handling of various QMS tools such as change control, deviation, CAPA, OOS, OOT, investigation, RCA, risk assessment, regulatory compliance, and gap assessment to ensure identified quality risk is proactively mitigated to ensure compliance with GMP standards and regulatory guidelines. Active participation in various regulatory.

Pune, Maharashtra, India

 Focused on Quality system development, implementation, and improvement for Biologics DS and DP manufacturing facilities to ensure robust quality systems. Managed all quality-related operations to ensure that system & processes are in compliance with SOP, cGMP and CMC regulatory standards. Responsible for providing expert QA guidance for change control.

Mumbai Area, India

 Developed proficiency in handling of deviations, change controls, CAPA, OOS and market complaints related to finished products. Developed a comprehensive understanding of Biopharma operations, including cleanroom setup and functionality. Acquired knowledge in biologics Drug Substance and Drug Product manufacturing. Supported validation efforts for.

Mumbai Area, India

 Routine IPQA visits in manufacturing areas to monitor and ensure manufacturing operations are carried out as per SOP and batch production records.  Area line clearance in warehouse and manufacturing areas. Review of executed batch records, SOPs, various GMP protocol & report. Participated in regulatory inspections, and customer audits. Supported.

Master Of Science - Ms, Biotechnology, A

Master Of Business Administration - Mba, Operation Management, First Class