Satish Aketi
Summary
Validation Professional with 5+ years of experience in Computer System Validation (CSV), QA, and Regulatory Compliance in the pharmaceutical industry. Skilled in preparing, reviewing, and executing validation deliverables including URS, IQ, OQ, PQ, risk assessments, and validation reports. Strong expertise in 21 CFR Part 11, EU Annex 11, and GAMP 5 with hands-on experience in PLC-SCADA, QC Systems, and HMI validations. Adept at cross-functional collaboration, technical writing, and ensuring compliance with GxP, cGMP, and GDP guidelines.
Overview
6
6
years of professional experience
Work History
Senior Validation Associate
IVY Works Advisors LLP
Bangalore
08.2023 - Current
- Responsible for writing Validation Documents including User Requirement Specifications, Design, Installation, Operational & Performance Qualification for equipment, utilities.
- Execution of protocols, deviation handling, change control, document control with on-site client vendor Co-ordination and getting approvals with comment incorporation.
- Experience in 'Computer System Validation of PLC-SCADA, PLC-HMI, QC System' and have knowledge and understanding about GAMP 5, 21 CFR part 11, EU Annex 11, Regulatory Compliance, GDP and cGMP.
- Maintaining safety, ensuring timelines are met & within the target budget along with the interactions with the vendors, contractors to meet the cGMP, ASME, ISPE & regulatory requirements and guidelines.
- Expertise in reviving of key deliverables Supplier assessment, Validation plan, User requirement specification (URS), Functional requirement specification, Design specification and Configuration specification in compliance and conformance against with validation guidelines.
- Expertise in reviewing and approving of qualification/testing documentation (IQ, OQ & PQ).
- Expertise in verification and evaluation of security management Electronic records and Electronic signatures deliverables as per 21 CFR Part 11 regulatory requirements.
- Experience in Incident, Defect, Deviation, CAPA, Change control and Risk Management & mitigation plan as per Quality Management System.
- Spread Sheet Validations
Junior Chemist (QA)
Gland Pharma Pvt Ltd.
Hyderabad
03.2020 - 04.2023
- Review and Approve of Computer System validation Documents.
- Review of User requirement specification, vendor assessments, GxP assessments, system level impact assessments.
- Review of Design documents (Design qualification, Functional specification, software and hardware specification).
- Identification of CSV deliverables.
- Review of Data Backup & Restoration activity for GxP system.
- Preparation, execution and review of Risk assessments, Validation Plan, IQ,OQ,IOQ,PQ, Traceability matrix and Validation Plan report.
- Preparation of cleaning validation protocols and reports.
- Cleaning verification protocols and reports.
- Matrix approach by PDE values.
- Monitoring all critical parameters.
- Respective change controls (Track wise) & trainings (TMS).
Education
M.SC - Orgonic Chemistry
Srinivasa Educational Society
Hyderabad01.2023
Bachelor of Degree - Chemistry
Modren Degree College
Tadepalligudem01.2018
Senior Secondary/Class XII -
Sri Aditya Junior college
Amalapuram01.2014
SECOUNDARY SCHOOL CERTIFICATE (SSC) -
Z.P.P.High School
Bheemanapalli01.2012
Skills
- V-Model
- FDA 21 CFR Part 11
- GAMP-5
- Software Validation
- PLC
- SCADA System Validation
- Regulatory Compliance Knowledge
- Risk Assessment and Mitigations
- SDLC
- GAMP 5
- MS Office (Word, Excel, Power Point)
Disclaimer
I hereby declare that, I look forward to any opportunity to discuss the position and what I can do for your company. I believe my vision and values align with the company(organization) and that I'd be an excellent fit for your organization. Thank you for your time in reviewing my resume.
Timeline
Senior Validation Associate
IVY Works Advisors LLP
08.2023 - Current
Junior Chemist (QA)
Gland Pharma Pvt Ltd.
03.2020 - 04.2023
M.SC - Orgonic Chemistry
Srinivasa Educational Society
Bachelor of Degree - Chemistry
Modren Degree College
Senior Secondary/Class XII -
Sri Aditya Junior college
SECOUNDARY SCHOOL CERTIFICATE (SSC) -
Z.P.P.High School
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