Piyush Singh
Rewa
Summary
To add value to the company with my Technical Skills, Computer System Validation, Documentation Skills and Software Skills help in building up a positive and quality environment, where my experience can be shared and enriched for the organization goals. Looking for a challenging opportunity to prove my ability and capability with my skills.
Overview
1
1
year of professional experience
Work History
Validation Engineer
GAMP SERVICES PVT. LTD
Indore
05.2024 - Current
- Worked on BMS & EMS System & QC Systems
- Handling the Company System Validation process of documenting based on FDA 21 CFR 11.10(a) And EMA annexure (11), Section (4)
- Hands-on Test Method Validation (TMV), and R&D experience
- Worked with many Automation and Process system Like: DCS, PLC, HMI, CDAS, DAS, SCADA custom software system Etc
- Expertise in conducting Risk Assessment, 21 CFR Part 11 Assessment, Security Assessment, and Documenting process as per GAMP 5 Category’s
- Heavy emphasis on Computer Software validation, Instrument/Equipment Validation, Cleaning and process Validation and Software Quality Assurance (SQA) with profound knowledge of FDA regulations, Documenting validation protocols, Documentation, LIMS, AERS
- Developed Validation Protocols like: Installation Qualification (IQ), Operation Qualification (OQ), Performances Qualification (PQ) as per the Specification and requirement and maintained Traceability matrix for various testing
- Reviewed and approved validation documentation for accuracy and completeness.
- Developed validation protocols for software applications and systems integration.
Education
Bachelor of Technology - Information Technology
I.P.S.T MGCGV
Satna (M.P)03-2017
HSSC -
M.P. Board
Rewa03-2013
HSC -
M.P. Board
Rewa03-2011
Skills
- Computer System Validation
- Data Migration
- URS
- FRS
- FAT
- SET
- IQ
- OQ
- PQ
- Validation Report
- Good Manufacturing Practice (GMP)
- GAMP
- GxP
- Validation
- US Title 21 CFR Part 11 Regulation
- US Food and Drug Administration (FDA)
- European guideline
- ERES
- Good Laboratory Practice (GLP)
- QSR
- Distributed Control System (DCS)
- Programmable Logic Controller (PLC)
- HMI Configuration
- CDAS
- DAS
- Documenting process
- GAMP 5 Category
Personal Information
- Father's Name: Mr. Balendra Singh Baghel
- Mother's Name: Ms. Sushma Singh Baghel
- Date of Birth: 30/01/1995
- Gender: Male
Languages
- English
- Hindi
Hobbies and Interests
- Playing Badminton
- Reading Book
- Traveling
Volunteer Experience
- National Certificated of The Bharat Scouts and Guides Camp New Delhi.
- Active member in Blood Donation Camps.
Timeline
Validation Engineer
GAMP SERVICES PVT. LTD
05.2024 - Current
Bachelor of Technology - Information Technology
I.P.S.T MGCGV
HSSC -
M.P. Board
HSC -
M.P. Board
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