Shafik Shaikh
Scientist- Formulation Analytical Research and Development Centre, Aurobindo pharma. Hyderabad
- Role
- Scientist-iii at Aurobindo Pharma Ltd
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
Experience
Scientist-iii
Nov 2013 — Present · Hyderabad, IN
Analytical method Development, Analytical method validation and Analytical method equivalency of various API, Excipient,solid dosage and Injectable dosage formulation (APL Research Center A Division of Aurobindo Pharma Limited) products by using HPLC, LC-MS, ICP-MS, ICP-OES and AAS. • Vendor qualifications as per ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. • cGMP, GLP implementation in daily operations of laboratory activity with particular emphasisemphasis. • Handling Incidents & Deviations in laboratory and investigation of OOT and OOS.• Reviewing all regulatory compliance materials artworks to guarantee accuracy, timeliness, comprehensiveness, and obedience with the standards. • Monitoring regulatory developments by establishing & maintaining good relations with relevant authorities • Interacting with regulatory department for approvals and update of new & existing applications. • Comparative study of samples with the market products and generating data & reports for the same. •Complete analysis of raw materials and reviewing & approving them. • Evaluating & reviewing the reports of QC for physical, chemical, sampling, examining and/or testing of raw materials, & finished products• DMF Review: Three bathes of vendor COAs/ FARD COAs/ Specifications/ MOAs. Validation of all unofficial tests such as Assay / RS/LOD/LOQ other than non compedial test and any. PSD/bulk density method followed at inhouse / vendors same or different if different proper justifications. Impurities structure, Force degration Data and Chemical Names. Any alternate API compilation. Proposed Limits strigent Or relaxed justification, Justification of all test specifications, classification of impurities(process and degradation) TSE/BSE/ Kosher/ Halal certificate/ MSDS availability.• TTD Review: 3.2.P.1 to 3.2.P.8.3• Studying the operational practices, identifying the areas of obstruction / quality failures.
Education
Swami Ramanand Teerth Marathwada University
Bachelor of Science (BSc), Science
Dr. Babasaheb Ambedkar Marathwada University, Aurangabad
MSc, Organic Chemistry
2007 — 2009
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