Mohd. Sadique Shaikh
Quality Head at Jay Precision Pharmaceuticals Pvt ltd a subsidary of Cipla Mumbai.(QMS/cGMP/MDR/RA/ISO 13485:2016)
- Role
- Deputy Manager at Cipla
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Mohd. Sadique Shaikh
I have 20 years of experience in Pharmaceuticals formulation and Medical device. I have worked in production, Regulatory, Quality Assurance, Corporate quality assurance and Quality Control. Standard : WHO GMP, cGMP, USFDA,ISO 9001:2015, ISO 13485:2016 and MDR2017. I am certified internal auditor by TUV rhinland. Documentation and Quality Management System. SMF, Quality Manual, medical device file, SOPs, Formats, BMR, BPR, logbooks, Specification, Test Data Sheet, COA, Change control,OOS, CAPA, Customer complaints. Vendor audit etc Stability Protocol and report, Qualification / Validation protocol and report. Device Master file as per MDR 2017. Change control, deviation, CAPA. ERP Validation as per GAMP5. Dossier CTD, ACTD & ECTD, Process validation, Method validation and DMF etc. Freelance Dossier preparation, DMF, Documents review. SOP preparation, Specification etc. Software validation : ERP
Experience
Deputy Manager
Mar 2014 — Present
Education
Shibli National College Azamgarh
BSc - Bachelor of Science
2001 — 2003
Arunodaya Degree and PG College
Master of Science - MS
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