Mohankumar K M
Associate Consultant
Bengaluru
Summary
As a seasoned quality professional with over 15 years of experience in pharmaceutical quality and compliance, I possess a unique blend of expertise in IT-LIMS implementation and pharmaceutical operations. Currently, I serve as Associate Consultant at Tata Consultancy Services in Bengaluru, where I successfully implement LabVantage LIMS solutions for global pharmaceutical clients.
My expertise spans formulation product testing, biologicals, analytical method validation, process validation, CSV, and Track wise. I'm well-versed in reviewing regulated documents for compliance with global regulatory requirements. My knowledge of regulatory frameworks includes 21 CFR, ICH guidelines, cGMP regulations, Quality Principles, GLP activities, and Data Integrity. I have successfully coordinated for regulatory audits (USFDA, MHRA, MCC, BRAZIL, and TGA) & other customer audits.
With my comprehensive experience and skills, I'm confident in my ability to make a valuable contribution to your organization.
Overview
15
15
years of professional experience
7
7
years of post-secondary education
1
1
Certification
3
3
Languages
Work History
Associate Consultant
Tata Consultancy Services
08.2023 - Current
- Responsible for implementation and operational usage support of Global LabVantage LIMS application (LV 8.7.1) for a global pharmaceutical clients.
- Currently working as business analyst cum project manager to implement the global LabVantage LIMS application for one of the global pharmaceutical companies, which has no exposure to LIMS.
- Implementation of LIMS by creating and validating their master data according to SAP interface, establishing instrument connections, configuring interface for Empower application for the complex QC methods.
- Worked on migration of data for couple of sites from their legacy LabVantage system (Sapphire LIMS) to the new validated global LIMS systems by extracting, analyzing and enriching the master data.
- Responsible for troubleshooting the incidents (L1, L2 level) arising from business (Pharmaceutical laboratory) users on various master data related issues, instruments configuration and parsing scripts, enhancing the complex calculations like groovy with the TAT and got appreciation from business with 100% CSI.
- In addition to, In-depth knowledge of LabVantage LIMS functionality, also aware of laboratory workflows, processes and regulations (e.g., GLP, GMP), familiarity with data management principles, including data quality, integrity and security.
- Ability to analyze business requirements, identify gaps and develop solutions.
- Familiarity with project management methodologies and experience with managing projects related to LIMS implementation.
- Acted as a liaison between stakeholders ensuring open lines of communication throughout project life cycle.
Associate Manager
Biocon Biologics
02.2020 - 08.2023
- Led the team of 9 members towards Compliance.
- Led team meetings regularly to discuss progress updates, identify challenges or roadblocks, and provide guidance towards successful completion of tasks with TAT.
- Collaborated closely with senior management on strategic planning efforts, aligning departmental goals with overarching company objectives.
- Established strong relationships with key stakeholders, fostering collaboration and mutual support.
- Lead for publishing QMS dashboard periodically.
- To review and manage analytical documents for Quality and compliance.
- Review and ensure OOS/OOT/OOAC/OOAL/LI/Deviations are investigated and appropriate CAPA's are identified and implemented.
- Review and identify areas of improvement in the analytical laboratories and implementation of 5S in the laboratory.
- Responsible for Internal Audit and Lab health check.
- Responsible for imparting training as part of analytical school
- Responsible for Global SOP s Simplification and revisions
- Ensure all instruments/equipment's and associated software's are meets the 21 CFR-Part11 compliance.
- Certified LSSGB from SKILL and Biocon Biologics for the Lab automation support and cost reduction.
- Recruited, interviewed and hired employees and evaluated employee performance and conveyed constructive feedback to improve skills.
Assistant Manager
GlaxoSmithKline Pharmaceuticals Ltd
02.2017 - 01.2020
- Led team of 5 members towards compliance.
- Involved in Laboratory set up for New Indian factory (Green field project at Vemgal, Bengaluru).
- Led weekly team meetings to discuss goals and review performance, fostering culture of continuous improvement.
- Lead for implementation of LabVantage LIMS application as a business user by coordinating with the service provider (TCS).
- Visited GSK,Jurong, Singapore plant to understand and learn the requirements of LIMS implementation at GSK, Vemgal site, Karnataka.
- Implemented LabVantage LIMS application by creation and validating the Master data objects and workflows. Also supported for creation of DCWs like Parameter, Parameter Lists, Test methods, Specifications, Limit sets etc. and guided provided training to the service provider consultants regarding the Methods, calculations setup (Groovy for the complex calculations), Instrument configuration and Empower application. Prepared UAT scripts and executed successfully and also provided technical support for the change requests.
- Responsible for Method Validations and Method transfers.
- Responsible for Lab Equipment/ Instrument (IQ, OQ and PQ activities) and CSV.
- Approval and release of Raw material/Packing material/ Finished product/Stability reports etc.
- To ensure adequate and timely review, implementation, approval and closure of investigations (Incidents, Deviations, out of trend results, out of specifications) and proposed appropriate CAPA's.
- Imparting training to the employees regarding Data Integrity, FDA warning letters and 483's.
- Conducting self-inspections/ internal audit in laboratory against 21 CFR part 11 compliance and GLP.
- Harmonization and preparation of QC SOP's and implementation of the same in concerned department.
Analyst
Apotex Research Pvt. Ltd
03.2011 - 01.2017
- Testing all the stages of formulation products (Tablets & Capsules) i.e.,Raw materials, In-process, Finished Product, Stability samples with Labware LIMS application.
- Review, approval of analytical reports i.e., Raw material/Packing material/ In-process/Finished/Stability reports in LIMS and release in SAP.
- To ensure adequate and timely review, implementation, approval and closure of investigations (Incidents, Deviations, out of trend results, out of specifications) and proposed appropriate CAPA's.
- Responsible conducting self-inspections/ internal audit in laboratory against 21 CFR part 11 compliance and GLP.
- Visited and worked at Apotex Inc.,Etobicoke, Canada plant for the USFDA audit GAP assessment activities and product and method transfer activities.
Lecturer
B.L.D.E. A's College of Pharmacy
03.2010 - 02.2011
- Teaching for D.Pharm, B.Pharm and M.Pharm students.
- Guiding for the M.Pharm students for the project activity (Research).
- Supported guide for the Ph.D Research activities.
Education
Master of Pharmacy - Medicinal And Pharmaceutical Chemistry
Rajiv Gandhi University of Health Sciences.
Bengaluru, India 01.2008 - 03.2010
Bachelor of Pharmacy -
Rajiv Gandhi University of Health Sciences.
Bengaluru, India 01.2003 - 12.2007
Skills
- LabVantage LIMS implementation
- Life Sciences Quality & Compliance
- QMS 5S
- GXP IT Quality
- ICH Guidelines
- GLP, cGMP regulations
- Regulatory audits
- 21 CFR CSV
- Lean Six Sigma green belt (LSSGB)
Certification
Lean Six Sigma Green Belt Certification (LSSGB) - SKILL
Interpersonal & Business Skills
- Understanding Laboratory operations, including workflows, processes and regulations.
- Ability to analyze business requirements and develop solutions to meet those needs.
- Familiarity with project management methodologies.
- Strong communication and interpersonal skills to effectively coordinate with stakeholders.
- Ability to work collaboratively with cross-functional teams.
- Strong problem-solving skills to troubleshoot issues and resolve conflicts.
- Commitment to ongoing learning and professional development to stay up-to-date with industry trends.
Instruments Handled
- HPLC - Make: Waters-2695, Agilent-1100, 1200 &1260 series, Shimadzu.
- UPLC - Make: Waters (Acquity) & Agilent 1290 series.
- GC - Make: GC-Agilent 6980 with G1888 Head-Space Sampler.
- DISSOLUTIONAPPARAUS - Make: Electro Lab & Distek with auto-sampler.
- OTHER INSTRUMENTS/EQUIPMENTS - UV-Spectrophotometer (Shimadzu-UV1700), IR, Bulk density apparatus, Analytical balance (Sartorius and Mettler Toledo), pH meter, Conductivity meter, Polarimeter, Hardness tester and Friabilator.
Software application knowledge
- Labware LIMS (Version 5): Used this application as end user and supported as QA reviewer during implementation.
- LabVantage LIMS : Version 7.0.2 (LIFT) - Supported for implementation and Version 8.7 (GLMW) - Supported for implementation.
- Track wise – Used this application as end user for tracking of QMS events and also supported for implementation.
- CDS Software – Empower (2 and 3), Used this application as end user.
- Standalone instrument software – Lab Solutions, UV Win Lab, Tiamo 2.4, Spectrum ES, Vision, Syngistix, Autopol V Plus, TOC-V, X'pert pro etc. - Used these applications as end user.
- SAP (ERP) - MERP - Used these applications as end user.
Personal Information
- Nationality: Indian
- Marital Status: Married
Present and Permanent address
Global Edifice Celesta Apartment, Flat No E-303, Chandapura, Bengaluru - 560081
Declaration
I hereby declare that the above information provided by me is true to the best of my knowledge and belief. I understand that any discrepancy will lead to the rejection of my candidature.
Timeline
Associate Consultant
Tata Consultancy Services
08.2023 - Current
Associate Manager
Biocon Biologics
02.2020 - 08.2023
Assistant Manager
GlaxoSmithKline Pharmaceuticals Ltd
02.2017 - 01.2020
Analyst
Apotex Research Pvt. Ltd
03.2011 - 01.2017
Lecturer
B.L.D.E. A's College of Pharmacy
03.2010 - 02.2011
Master of Pharmacy - Medicinal And Pharmaceutical Chemistry
Rajiv Gandhi University of Health Sciences.
01.2008 - 03.2010
Bachelor of Pharmacy -
Rajiv Gandhi University of Health Sciences.
01.2003 - 12.2007
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