Rakesh Jakkashetty
Angestellt, Technical Support for Aseptic Production, Novo Nordisk
Copenhagen, Dänemark
Über mich
I am an assertive and passionate pharmaceutical professional, having 9 years’ industrial experience, which includes people management and technical in terms of Equipment Validation, Production operations, Quality Management System, Cleaning Validation (Protocol & report preparation, MACO Calculations, Sampling & Execution), Audit & Compliance, which includes a high level of professional competencies and proven track records. I have obtained valuable experiences, and good knowledge of GMP regulations such as EMA, USFDA, MHRA, TGA, HPRA, and SFDA. Having good interpersonal and intercultural communication skills; I love to interact with different people & have the patience to listen to them. I worked in different pharmaceutical / Biopharmaceutical companies which comprise green-field & brown-field projects.
Werdegang
Berufserfahrung von Rakesh Jakkashetty
2 Jahre und 10 Monate, Juni 2019 - März 2022
Manager - Aseptic Operation
Saudi Biotechnology Manufacturing Company
• 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.
11 Monate, Juli 2018 - Mai 2019
Senior Executive
Accord Life Spec Pvt Ltd
• 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.
7 Monate, Dez. 2017 - Juni 2018
Senior Executive Quality
Cipla Ltd
• 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.
6 Monate, Juli 2017 - Dez. 2017
Executive
Wintac Ltd
• 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).
5 Jahre und 1 Monat, Juli 2012 - Juli 2017
Associate
Mylan
• 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
Ausbildung von Rakesh Jakkashetty
3 Jahre und 1 Monat, Juni 2009 - Juni 2012
Biotechnology
University of Mysore
Biotechnology and Chemistry
Sprachen
Englisch
Fließend
Deutsch
Grundlagen