Manjunath Mupparapu
Global Computer System Validation Quality Expertise
Bengaluru,KA
Summary
To integrate the knowledge and experience that I gain during my career and utilize it optimally for fulfilment of my job responsibilities that I own in an organization.
I am Global Computer System Validation Quality Expert associated with Haselmeier (A medmix Brand) handling global projects across our entities. I have 10+ Years experience in Process Development, Quality Functions in Pharmaceutical and Medical Device Industry.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Global CSV Quality Expert
Haselmeier
09.2022 - Current
- Company Overview: (A medmix Brand)
- Own up CSV process, implement, and streamline with updated regulatory standards.
- Train and guide stakeholders’ (System owners, Business IT, system key users, validation engineers) on latest CSV standards.
- Review and approve the CSV deliverables for global validations, maintain inventory, vendor management.
- Perform Subject Matter Expert role in change request and computer system periodic review.
- Support validation of software as a medical device.
- Support resolving quality events (deviations, failure analysis) with the system performance knowledge.
- (A medmix Brand)
- Solid knowledge on GAMP5 risk based approach, FDA 21 CFR Part 11, FDA 21 CFR Part 2101EU GMP Annex 11, ISO 13485, IEC 62304, ISO 14971, V-Model, Lean and Six Sigma, Statistical data analysis.
Validation, Technology Transfer
Aurobindo Healthcare
11.2018 - 08.2022
Process development, MES, CS validation
Strides Pharma Ltd.
07.2016 - 11.2018
Equipment Qualification and Infrastructure Validation
Cipla Ltd.
09.2013 - 06.2016
- Hands on experience in deriving a validation strategy with critical thinking and risk based approach.
- Effective in planning, preparation, review, and approval of validation deliverables (protocol & reports).
- Ensure execution of system validation as per the Validation Master Plan.
- Expert in Change Management, Risk Assessment/ Impact Assessments as a part of computer system validation.
- Review User Requirement Specification, design specification, Test protocol (IQ/OQ/PQ,) and Validation summary reports, Risk Assessment reports.
- Technical review of change requests associated with Global CSV projects.
- Providing guidance and support to system owners / key users for setting up the system specific plans and reports for validating computerized systems.
- Performing periodic system reviews in collaboration with the system owner and IT.
- Expertise in equipment and IT infrastructure Qualification (in Pharmaceutical and Medical device segment)
Education
Masters - Pharmaceutical Science and Technology
JNTU
01.2013
Bachelor - Pharmaceutical Science and Technology
JNTU
01.2010
Diploma - Honors Diploma in Computer Application
C.S.C
01.2008
Certification
- ISO 13485:2016 Lead Auditor, TUV SUD, 70%
- Statistical Thinking and Problem Solving, SAS via Credly, 80%
- Lean Six Sigma Black Belt (ICBB), Anexas Europe, 85%
- International English Language Testing System (IELTS), British Council, Proficient
- Graduate Pharmacy Aptitude Test, National Testing Agency, 5182 All India Rank
- International Society for Pharmaceutical Engineering membership, ISPE, Active Member
Languages
English
Advanced (C1)
Hindi
Upper intermediate (B2)
Telugu
Bilingual or Proficient (C2)
Kannada
Upper intermediate (B2)
Tamil
Beginner (A1)
German
Beginner (A1)
Personal Information
- Father's Name: Mupparapu Panduranga
- Child Name: Mupparapu Karthikeshwar
- Date of Birth: 01-07-1988
- Gender: Male
Spouse
Haritha
Hobbies and Interests
- Discovery Science & BBC World News
- Playing chess
- Playing with my son
- Avid reader of scientific informative portals like science direct, PubMed
Disclaimer
I hereby confirm that all the facts stated above are accurate to the best of my belief.
Timeline
Global CSV Quality Expert
Haselmeier
09.2022 - Current
Validation, Technology Transfer
Aurobindo Healthcare
11.2018 - 08.2022
Process development, MES, CS validation
Strides Pharma Ltd.
07.2016 - 11.2018
Equipment Qualification and Infrastructure Validation
Cipla Ltd.
09.2013 - 06.2016
Masters - Pharmaceutical Science and Technology
JNTU
Bachelor - Pharmaceutical Science and Technology
JNTU
Diploma - Honors Diploma in Computer Application
C.S.C
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