I am 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, ISO 9001:2015 , ISO 13485:2016
MDR2017
I am certified internal auditor by TUV Rhinland.
Documents in which I am dealing...
SMF, Quality Manual , medical device file,
SOP, Formats, BMR, BPR, logbooks, Specification , Test Data Sheet, COA etc.
Stability Protocol and report,
Qualification IQ,OQ,PQ / Validation protocol and report.
Device Master file as per MDR 2017.
Change control , deviation, CAPA.
ERP Validation as per GAMP5.
Dossier, Process validation, Method validation and DMF etc.
If any thing required please do let me know..