Manjunath Shetty

Results-driven Quality, Compliance, LIMS and Computer System Validation (CSV) professional with 17+ years of experience in Quality Control, Quality Assurance, Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS), Data Integrity, Regulatory Compliance, and Computerized System Validation within the pharmaceutical industry. Experienced in leading LIMS implementation projects, laboratory digital transformation, process improvement initiatives, gap assessments, regulatory inspections, vendor management, and compliance programs.

Manager – Quality Control & LIMS/CSV Lead - Maiva Pharma Pvt. Ltd. - Hosur

(2025-04)

• Leading end-to-end LIMS implementation and administration across QC laboratories.
• Managing cross-functional teams and coordinating QC, QA, IT, Engineering and vendors.
• Driving people management activities including mentoring, training, workload allocation and performance monitoring.
• Managing master data creation, review and approval for products, specifications, instruments and users.
• Conducting gap assessments between laboratory processes and LIMS requirements.
• Driving process improvement and laboratory digitalization initiatives.
• Ensuring compliance with cGMP, GAMP 5, 21 CFR Part 11, EU Annex 11 and Data Integrity requirements.
• Reviewing URS, FS, Risk Assessments, RTM, IQ/OQ/PQ protocols, reports and validation summary reports.
• Managing change controls, deviations, CAPA and risk assessments.
• Leading UAT, system testing, training and go-live support activities.
• Performing audit trail reviews, periodic reviews and access management reviews.
• Coordinating with vendors for issue resolution, enhancements and system support.
• Supporting regulatory inspections, customer audits and computerized system compliance audits.
• Driving inspection readiness and continuous compliance monitoring.

Lead Executive – Corporate Quality Assurance - Apotex Research Pvt. Ltd. - Mumbai

(2018-04 - 2025-03)

• Reviewed and approved validation lifecycle documents for GxP computerized systems.
• Managed Change Controls, CAPA, Deviations, Audit Trails, OOS/OOT investigations and QMS activities.
• Supported implementation and maintenance of LIMS and Quality Systems.
• Performed compliance assessments against GAMP 5, Annex 11 and 21 CFR Part 11.
• Supported USFDA, MHRA, WHO, ANVISA and Health Canada inspections.

Senior Executive – Quality Control - Aurobindo Pharma Ltd. - Hyderabad

(2015-12 - 2018-03)

• Managed qualification and validation of laboratory instruments and systems.
• Performed risk-based testing and data integrity reviews.
• Supported stability programs and APQR activities.

Executive – Quality Control - Shilpa Medicare Ltd. - Hyderabad

(2014-10 - 2015-12)

• Executed analytical method validation and transfer activities.
• Maintained LIMS records and laboratory compliance documentation.

Senior Executive – Quality Control - Strides Arcolab Ltd. - Bangalore

(2011-05 - 2014-10)

• Managed Change Controls, Deviations, CAPA and OOS investigations.
• Reviewed analytical data and quality documentation.

Senior Executive – Quality Control - Hikal Ltd. - Bangalore

(2009-01 - 2011-05)

• Handled analytical QC activities and method transfer programs.
• Supported audit preparation and inspection readiness.

M.Sc. - Pharmaceutical Chemistry - Gulbarga University

B.Sc. - Microbiology - Government College, Gulbarga