Chemist
Herbalife International
Total years of experience :8 years, 11 Months
(NABL accredited Laboratory - ISO 17025)
• Prepared and executed protocols, reports and relevant documents for in-house use and Method Transfer activities to Manufacturing sites.
• Successfully carried out method transfer activities from global teams of the Organization to India Centre of Excellence and transferred the same to Contract Manufacturing Unit for Analytical testing of products.
• Investigational (Query) samples' analysis which involve both raw material analysis and post market surveillance of finished products.
• Carried out Method Verification activity of Compendia methods (USP, AOAC and IS) .
• Site validation (Partial Validation) of HPLC methods.
• Method Feasibility studies to support regular R&D activities.
• Stability testing, OOS investigations, Process Validation analytical studies like Blend Uniformity studies.
• Evaluated products for their ingredients and claim correctness by Instrumental and Wet analytical methods as per Regulatory requirements.
• Prepared Value Stream mapping (VSM) templates for analytical methods which helped to improve productivity.
• Perform intermediate checks and periodical calibration of equipment like HPLC - PDA, UV, RI, FLR, FOSS Kjeltec 8400 autosampler unit.
• Coordinated with service engineers for IQ, OQ and Annual Preventive Maintenance of laboratory Equipment and performed PQ.
• Indented and maintained CoAs of lab supplies (like chemicals, reagents, glassware and analytical standards) as per the regulatory requirements by coordinating with the suppliers.
• Prepare script and training videos on Instrumental Analysis and procedures as a source of knowledge for Global teams.
• Hosted intra departmental knowledge sharing sessions.
• Certified Green Lab Ambassador.
Credits at Job:
• Recognised for critical and expedited analytical support in very short notice for product launch in 2023.
• Recognised for smooth and successful method transfer activity to Contract Manufacturing Unit.
• Recognised for identifying the gaps in product specifications and giving valuable inputs for QbD .
• Preparation of Method development documents and Stability protocols.
• Analytical Method Development, Partial Validation of Finished Products and raw materials of Functional Food, Animal Health and Pharmaceutical products by HPLC and Gas Chromatography.
• Alternate Vendor Development for raw materials (for active marker assays and parameters critical for finished product claims) and prototype analysis in NPD R&D.
• Extensively worked on Vitamin and mineral premixes, specialty nutrients to support the label claims on products. Provided support to Project Management team and Formulation R&D in multiple innovation and renovation projects.
• Performed periodic calibration and troubleshooting of HPLC.
• Maintenance of Reference Standards and Working Standard Qualifications by HPLC.
• Trained project interns, intra- and inter-departmental personnel on newly implemented methods practically.
• Addressed customer and regulatory queries about label claimed ingredients.
• Competitive products’ screening and testing for innovation and new claims.
Credits at Job:
• Contributed in cutting down the cost of Analyses for “Determination of Dietary Fibers by AOAC kit method”. Established the method in-house by conducting seminar and training personnel of R&D and QC thereby making the Organization not to rely on third party for the same.
• Carried out infusion study for Green Tea: A unique study to scientifically support the label claim of EGCG and Total Catechins which was carried out by HPLC method developed and validated in- house.
• Received appreciation for specialty nutrient determination by HPLC which helped to address customer’s query immediately.
Specialization: Pharmaceutical Analysis and Quality Assurance CGPA: 8.53 Secured seat with National Level Entrance Exam qualification GPAT (Formerly GATE) - All India Rank 674
Various subjects like Physical pharmacy, Organic chemistry, Inorganic Chemistry, Biochemistry, Biotechnology, Microbiology, Anatomy and Physiology, Pharmacognosy, Pharmaceutics, Pharmaceutical Engineering, Medicinal Chemistry, Chemistry of Natural products, Pharmacokinetics, Pharmaceutical Analysis