Rakesh Jakkashetty

• Responsible for Project Quality operations & Validations as a TL & SME. Driven Finished Production department from Project stage to Operational Stage. • SME for QMS – Deviations, Change Management, CAPA & investigations. • Proven Track record on Audit & Compliance. Successfully completed Eu & SFDA audit and Customer audits. Hands-on Experience in Internal & External audits. Ensures Data integrity • Proven records on Risk Management, experienced in QBD.

• Experienced in Green Field Oncology Project. • Authored & Executed CV Protocols, Equipment Validation Documents (VMP, VP, Impact Assessments, Risk Assessments, Traceability Matrix, Design documents), Computer System Validation Documents, and Procedures (SOP). • Qualified Isolators, LAF, Autoclave, Lyophilizer & Serialization Systems. • Risk management & QMS Activities handled. Proven track record on implementation of Lean Six Sigma DMAIC to Project Validation Operations & Visual Inspection Process.

• Key Personnel in Oversight and QA Audit & Compliance activities. • QMS Co-ordinator & Quality investigator for oncology unit. • Implemented Visual inspection & AQL Procedure in line with USP & Eu GMP. • Performed Process Validations, Cleaning Validation & Transport validations. • Authored & Executed Validation documents Such as Cleaning Validations (Cleaning validation approach & Sampling plans), Equipment Validations & Computer System Validations.

• Validation & Quality Management System Co-ordinator for department. • Authored & Executed Cleaning Validation Protocols, Equipment Validation Documents (VMP, VP, Impact Assessments, Risk Assessments, Traceability Matrix, Design documents, FAT, SAT, IQ, OQ, PQ, RQ), Computer System Validation Documents (GxP, Software Hazard Analysis, RA, DQ, IQ, OQ), and Procedures (SOP). • Qualified & Implemented Serialization System (Profix) up to Regulatory interface (Tracelink & RfxL).

• Department co-ordinator for QMS, such as investigations, Change controls, Training & Gap Assessment. • Process owner & team member for Equipment Qualifications Such as Leak test machine, Automatic Visual inspection machine. • Implemented Six Sigma for Visual inspection System to increase the output. • Risk management & QMS Activities handled and Co-ordinator for CSV. • Key Personnel for validation compliance activities, as per ISPE, Eu GMP Annex 15, USFDA, 21 CFR part 11 & Eu Annex 11 compliance

Biotechnology and Chemistry