M. Vivekanandan

Quality Control and Analytical Development professional with over 20 years of experience in the pharmaceutical industry. Currently serving as Deputy Manager at Strides Pharma Science Pvt. Ltd., Chennai. Overseeing the Lab Support team and previously managing responsibilities in Analytical Validation, Transfer, IPFP, and Instrument Qualification teams. Demonstrated expertise in analytical method validation, method transfer, regulatory compliance (FDA, MHRA, ISO standards), and lab support functions. Extensive knowledge of cGMP practices, handling sophisticated analytical instruments (HPLC, GC, LCMS, UV-Vis, FTIR), and utilizing advanced documentation systems like LIMS, Track Wise, and e-Valgenesis. Skilled in preparing risk assessments for nitrosamine and elemental impurities in alignment with global regulatory requirements. Leading regulatory audits (US FDA, MHRA, WHO), ensuring smooth execution of lab activities, method validation, and compliance documentation. Adept at mentoring teams, driving continuous improvement initiatives, managing complex analytical projects with a proactive and result-oriented approach while upholding the highest quality standards in pharmaceutical analysis and development.

• High Pressure Liquid Chromatography (Models: Waters, Agilent, Dionex)
• LCMS (Waters)
• AAS (Perkin Elmer)
• Gas Chromatography (Model: Perkin Elmer and Agilent)
• Ion Chromatography (Dionex)
• Dissolution Apparatus (Electro lab, Lab India)
• UV-Visible Spectrophotometer (Shimadzu)
• DSC, TOC, FTIR, Polarimeter, Viscometer (Brookfield) and KF
• Raman IR
• PSD by Malvern 2000 and Malvern 3000

• Tablets: Combination products, Immediate release, Extended-release tablets, Sustained release tablets, Modified release tablets
• Capsules: Hard Gelatine capsule, Pellets in capsules (both extended release and IR)

• Ensure timely deliveries
• Interact with other functions
• Interact with external vendor
• All time lab compliance

• Implementation of good laboratory practice in the laboratory
• Successfully coordinated for US FDA audit, MHRA audit, ISO audit and WHO audit

• Date of Birth: 04/10/81
• Nationality: Indian
• Marital Status: Married

• Proactive approach in problem solving and system improvement
• Team leadership Qualities
• Technical Skills
• Initiatives to learn new things
• Self-Driven
• Time Management
• Interpersonal Skills
• Communication Skills
• Mentoring and Multi-tasking Skills