A. SURESH CHANDRA DORA
Bengaluru
Summary
Seasoned QA professional with a robust background in QMS & Compliance and Process Validation & Risk Assessment, honed at Macleods Pharma Limited and other leading pharmaceutical firms. Excelled in SOP creation and implementation, demonstrating exceptional analytical and leadership skills. Proven track record in enhancing audit compliance and operational efficiency through strategic Qualification & Validation initiatives.
Overview
9
9
years of professional experience
Work History
Senior Executive - QA
Medreich Pharma Limited
BANGLORE, Karnataka
03.2023 - Current
- Handling Qualification & Validation processes
- Managing QMS activities: Change Control, CAPA, Deviation, CAPA, Deviation
- Annual Product Quality Review (APQR) and Audit Compliance
Senior Officer - QA
Macleods Pharma Limited
05.2020 - 03.2023
- Led QMS activities, including Change Control and CAPA Management
- Conducted Risk Assessments and Cleaning Validation
Senior Officer - QA
Mylan Pharma Limited
07.2016 - 04.2020
- Conducted IPQA activities, Cleaning Validation, and Risk Assessment
- Managed Change Control procedures for compliance
- Overseas experience: Worked in Zambia (3 months) on an on-job transfer
Education
M.Pharm - Pharmaceutics
Dr. H.S. Gour Central University
Sagar, M.P01.2016
B.Pharm -
Biju Patnaik Technical University
Odisha01.2014
Skills
- Qualification & Validation
- QMS & Compliance
- Audit & Regulatory Compliance
- Process Validation & Risk Assessment
- SOP Creation & Implementation
- Batch Release & Documentation
- SAP & Electronic Logbook Implementation
Certifications And Achievements
- GPAT & NIPER Qualified (2014)
- AICTE Scholarship - MHRD (Govt. of India) 2014-16
- 8th Rank in Odisha JEE (M.Pharm Entrance Exam)
- Presented Posters at International & National Conferences (2014-15)
Personal Information
- Date of Birth: 05/26/92
- Nationality: Indian
Languages
- English
- Hindi
- Oriya
- Telugu
Disclaimer
I hereby declare that the above-mentioned information is true to the best of my knowledge and belief.
Audit Experience
- USFDA (Mylan, 2017 & 2018; Macleods, 2021)
- EU Audit (Medreich, 2023)
- Regulatory & Customer Audits (MHRA, ANVISA, WHO, TGA, SHAPRA)
Activities
- Led Equipment Qualification (IQ, OQ, PQ protocols & execution)
- Spearheaded Computer System Validation (SAP-PPM, Electronic Batch Records).
- Managed Cleaning Validation and Market Complaint Investigations.
- Co-ordinated inter-departmental QMS activities and Monthly Quality Review Meetings.
Timeline
Senior Executive - QA
Medreich Pharma Limited
03.2023 - Current
Senior Officer - QA
Macleods Pharma Limited
05.2020 - 03.2023
Senior Officer - QA
Mylan Pharma Limited
07.2016 - 04.2020
M.Pharm - Pharmaceutics
Dr. H.S. Gour Central University
B.Pharm -
Biju Patnaik Technical University
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