Analytical Devlopment Supervisor
SPIMACo
Total years of experience :27 years, 8 Months
• Coordinate with the Manager in preparation of strategies and action plans pertaining to development of projects.
• Daily planning of Testing on priority basis and distribution thereof to Analytical Development section work to junior analyst.
• Focus on Analytical method development activities for new pharmaceutical products in various dosage forms including drug substance, immediate and modified release formulations, syrup, suspension, oncology and aseptic products.
• Analyzed for the Injectable preparation Like Insulin (Normulin, Fastulin and Mixtuline), Rofenac Injection, Feldene Injection, Gentum Injection and Ferrosac Injection.
• To Ensure that the departmental activity are carried out smoothly and effectively as per cGMP norms.
• Assist the formulation development team pertaining to performance of formulation studies (testing formulation development samples, evaluation of formula, testing and compatibility of excipients among others).
• Checking and Review of Analytical Test Method Reports for in-process development lots, stability batches and Test & Reference samples besides preparation of Certificate of Analysis of finished products for registration purposes.
• Generate in-vitro drug release profile for test and reference products in different media to establish in-vivo performance of the test product for Bioequivalence study.
• Involved in various activities related to shelf-life extension of existing products; coordinate writing, reviewing of SOPs, Method Validation Protocols & Reports, Stability Testing Protocols & Reports and Progress Reports besides focusing on revision and approval as applicable.
• Preparation of quality control test methods, sampling instruction, designing of in-process, release, shelf life & purchase specifications for both raw materials and finished products.
• Evaluate licensor technical capability for sustainability apart from being involved in verification of analytical test methods. Analytical Method transfer from the Licencor product.
• Development and approval of analytical testing methods for new Raw Materials (API).
• Ensure continued and cost effective supply of raw materials through development of multiple suppliers/vendors; justify set specifications for raw materials and finished products based on ICH/FDA/EMEA & other regulatory guidelines, stability data, compendia monographs and available technical dossiers.
• Preparation of validation reports for assay, impurities, RS, dissolution test method using UPLC, HPLC, TLC, GC, UV, dissolution and other analytical techniques; qualification and maintenance of in-house working standards, design and/or implementation of strategy for characterization & assignment of expiration dating.
• New Instruments Purchase and handling of Instrument Spare Parts, maintenance, related work like Job Work Orders and follow-ups.
• Monitoring & scheduling of activities for calibration and maintenance of all laboratory instruments; management of change control & investigations, troubleshooting, recommendation of corrective action and implementation of solutions pertaining to analytical methodology, finished product process, characteristic and quality.
• Analyzed various types of drugs like Analgesics & Antipyretics, alimentary drugs, antibiotics, anti-inflammatory, Bronchi spasm Relaxants, Cardiovascular drugs, Expectorant & Cough suppress, Eye, Ear &Nasal Preparation, Sedatives & Tranquillizers drugs, Topical Antifungal & Anti-infective Preparation, Vitamins, Minerals & Digestive Enzyme Preparation based on Indian Pharmacopoeia, British Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, and Patent proprietary.
• Involved in calibration of all major instruments, preparation of Standard Operating Procedure and identification of Ayurvedic Sample by using TLC & HPTLC procedures.
• Developed analytical methods for various types of drugs besides being involved in analysis of development method of multivitamins through HPLC and other instruments.
• Conducted excise related sampling for alcohol, beer, whisky, cologne water, hair stylish gel and other products.
• Also involved in analysis of cosmetics related sample like hair oil, shampoo, lipstick, nail polish based on Indian Standard Institute (ISI) guidelines.
• Involved in analysis of various types of raw materials of Organo phosphorus Pesticides, preparation of formulation batch quantity using the potency calculation and finalization of batch card.
• Analyzed on-line process sample and finished products for agrochemicals products like Monochrotophos, Chlorpyriphos, Dichlorovos, Lusulphan, Fenveralate, Quinalphos, Ethion, Carbendazim, Mancozeb etc based on ISI and in-house Method.
• Developed new method for Emulsifying Concentrate using Supplier Emulsifier.
• Also involved in analysis and comparison of Stability of Process samples and Reference samples.