MANIKANDAN L
Senior Executive
Salem
Summary
Working as Senior Executive in Quality Control department, for OneSource Specialties Pharma Ltd), having over 10 years of pharmaceutical analytical expertise in API, oral solid dosage form and sterile injectables. Demonstrated performance history at prestigious organizations like Biocon Ltd., Adcock Ingram, and Anthem Biosciences. Competent in carrying out analytical testing, developing and validating analytical methods, and making sure documentation complies. Proven ability to handle audits from the USFDA, MHRA, at upholding industry best practices and regulatory standards, guaranteeing compliance with safety, GMP, GAMP, 21CFR and cGMP regulations.
Overview
11
11
years of professional experience
2
2
years of post-secondary education
3
3
Languages
Work History
Senior Executive in Quality Control Department
OneSource Specialty Pharma Ltd
01.2023 - Current
- Reviewing the in-process, finished products, raw material and stability samples using HPLC, GC, ICP-MS, AAS, PSD, UTM and UPLC.
- Support audits (internal and external), inspections (e.g., by regulatory authorities), and readiness activities.
- Perform quality oversight for QC labs, including data integrity checks, environmental monitoring review, and test method verification.
- Support investigation of quality events (deviations, OOS, OOT), assist with root cause analysis, and contribute to corrective and preventive actions (CAPAs).
- Coordinate and manage document control processes including SOPs, protocols, and work instructions.
- Participate in cross-functional project teams to ensure quality requirements are met during product development and manufacturing.
- Assist in training and mentoring of staff on GMP principles and quality practices.
- Support the qualification and maintenance of controlled environments, equipment, and instruments in collaboration with QC and engineering teams.
- Handling of QMS-Change controls, deviations, and CAPA.
- Preparing analytical method validation, verification, and transfer protocols and reports.
- Review of computerized system documents concerning 21 CFR Part 11.
- Maintaining logbooks, registers, and documents in QC online.
- Maintaining all analytical equipment/instruments and chemicals and standards in QC.
- Preparing SOPs, URS, QRM, Change Control documents, and LIMS product preparations.
- Review of QMS/Change Control in track wise and documents in EDMS as per requirement.
- Author, maintain, and implement critical QC documentation including SOPs, test methods, protocols, sampling plans, certificates of analysis, and reports.
- Manage the installation, calibration, and routine use of analytical instruments and laboratory systems (e.g., LIMS, EDMS, e-Valgenesis software).
- Contribute to project management efforts within the QC function, identifying opportunities for process improvement and efficiency.
- Actively engage in cross-functional team meetings, providing clear and timely communication on QC-related matters.
- Conducted and reviewed CSV protocols for OQ and PQ for new instrument qualification in e-Valgenesis and executed instrument qualifications like OQ and PQ in e-Valgenesis.
- Responsible to coordinate with Engineering and Maintenance team and external vendor for Instrument qualification, preventive maintenance and calibration activities.
- Interaction with production, ADL, R&D, QA, regulatory, client and Project team and other stakeholders for QC documentation related functions and smooth functioning of project related activities.
Senior Scientist in Quality Control Department
Anthem Biosciences Pvt Ltd
06.2021 - 01.2023
- Method Development and Validation: Developed and validated analytical methods using ICP-MS and PSD, prepared method validation protocols and reports, and conducted analysis of in-process, finished product, and raw materials.
- Equipment Management: Troubleshot analytical equipment failures and instrument malfunctions, demonstrating proficiency in using laboratory equipment such as PSD, ICP-MS, and TOC.
Executive in Quality Control
Adcock Ingram
01.2018 - 04.2021
- Analytical Testing: Conducted finished product and stability sample analysis using Caliber LIMS.
- Documentation and Compliance: Prepared Standard Testing Procedures and Analytical Data Sheets, maintained electronic worksheets, managed data entry and worksheet preparation, and ensured adherence to cGMP, GLP, and ICH guidelines.
Senior Executive in Quality Control
Biocon Limited
09.2014 - 01.2018
- Analysis: Analyzed in-process, finished product, stability, and cleaning validation samples, providing analytical support for synthetic chemical in-process samples.
- Documentation and Compliance: Ensured proper documentation, including checking online records, verifying standard availability, and maintaining lab temperature logbooks.
Education
Master of Science - Biotechnology
KSR College of Arts And Science College
Tiruchengode 04.2012 - 01.2014
Skills
- LIMS
- TrackWise
- e-Valgenesis
- EDMS
- SAP
- HPLC – Agilent 1260, 1200
- HPLC - Waters e2695 & e2998
- UPLC - Waters Series Acquity H Class Plus
- Gas Chromatography - Agilent 6890, 7890
- Gas Chromatography - PerkinElmer Clarus
- ICP-MS - Perkin Elmer NexIon 350X
- ICP-MS - Thermo Fisher Scientific
- Particle Size Analyzer - Malvern
- Karl Fischer Auto Titrator - Metrohm
- Dissolution Apparatus
- Disintegration Tester
- AAS
- UTM Universal Testing Machine
Timeline
Senior Executive in Quality Control Department
OneSource Specialty Pharma Ltd
01.2023 - Current
Senior Scientist in Quality Control Department
Anthem Biosciences Pvt Ltd
06.2021 - 01.2023
Executive in Quality Control
Adcock Ingram
01.2018 - 04.2021
Senior Executive in Quality Control
Biocon Limited
09.2014 - 01.2018
Master of Science - Biotechnology
KSR College of Arts And Science College
04.2012 - 01.2014
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