Suba Samba Sivam .C
Pharmaceutical life science
Denkanikottai,Tamilnadu
Summary
Dynamic validation specialist with extensive experience at Mylan Laboratory Ltd, excelling in Computer System Validation and quality risk assessment. Proven ability to manage change control processes and lead teams effectively. Adept at ensuring compliance with 21 CFR Part 11 and GAMP guidelines, driving operational excellence and enhancing vendor relationships.
Overview
10
10
years of professional experience
Work History
Assistant Manager
Maiva Pharma Pvt Ltd
Hosur
12.2024 - Current
- Handling of change management review, approval, sharing with third-party customers, and responding to the queries. Vendor Management - Performing third-party audit.
- The review of high-level risk assessment includes GxP assessment, GAMP categorization. Responsible for reviewing all levels of CSV validation documents, including Validation Plans and User Requirement specifications.
- Experience in the Software Development Life Cycle (SDLC), V-Model, and Agile.
SENIOR EXECUTIVE
Mylan Laboratory Ltd
Bangalore
11.2016 - 12.2024
- A review of high-level risk assessment includes GxP assessment, GAMP categorization, criticality assessment, and ERES applicability assessment.
- Responsible for reviewing all levels of CSV validation documents, including validation plans and user requirement specifications.
- Expertise in the verification and evaluation of electronic records and electronic signature deliverables, as per 21 CFR Part 11 regulatory requirements.
- Experience in the Software Development Life Cycle (SDLC), V-Model, and Agile.
- Performing an internal audit.
- Performing a quality risk assessment.
- Handling of EQMS elements such as Change control, deviation, CAPA, and root cause analysis in TrackWise.
- Expertise in documenting review and qualification protocols.
- Excellent experience as a validation specialist and in-depth involvement in writing test scripts for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).
- Experienced in periodic review to confirm that the computerized system remains in a valid state and is compliant with regulatory and standard requirements.
- Good knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Change Management: Review and Approval of Change Controls, Task Creation, Final Closure.
- Involved in media fill execution and involved in media fill visual inspection on the 7th and 14th days.
- Preparation, review, and approval of SOP, BHRand all protocols in D2.
Chemist
Softgel Health care PVT LTD
Chennai
05.2015 - 10.2016
- I'm responsible for the preparation of the master BMR, BPR, and STR. Coordinators for change control in TrackWise and D2 Documentum. And I had experience in IPQA.
Education
M.Pharm - Pharmaceutical Analysis
Tamil Nadu Dr MGR University
Chennai01-2018
Bachelor of Science - Pharmaceutical Medicine
Tamil Nadu Dr MGR University
Chennai10-2013
Skills
- Computer System Validation
- Vendor management
- EQMS and QMS
- 21 CFR Part 11
- GAMP and EU Annex 11
- ICH Q9
- Audit & Inspection
- GAP Analysis
- URS, FRA , VP, FS
- IQ
- OQ
- PQ
- SOPs Development
- CAPA Review
- Change Management
- Training & Development
- Risk assessment
- Validation documentation
- Software development life cycle
- Electronic records
- Quality risk assessment
- Customer relationship management
- Effective communication
- MS office
Industries
- Pharmaceuticals
- IT
Software Implemented
- D2 Documentum
- MES (Commissioning and Qualification)
- Validation Master Plan (VMP)
- QMS (Quality Management Systems)
Audits
- USFDA
- ANVISA
- INVIMA
- MHRA
- WHO
Personal Information
Date of Birth: 11/28/89
Languages
- English
- Tamil
- Telugu
Languages
Tamil
First Language
English
Proficient (C2)
C2
Telugu
Beginner
A1
Timeline
Assistant Manager
Maiva Pharma Pvt Ltd
12.2024 - Current
SENIOR EXECUTIVE
Mylan Laboratory Ltd
11.2016 - 12.2024
Chemist
Softgel Health care PVT LTD
05.2015 - 10.2016
M.Pharm - Pharmaceutical Analysis
Tamil Nadu Dr MGR University
Bachelor of Science - Pharmaceutical Medicine
Tamil Nadu Dr MGR University
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