Susheel Singh

Technical Director Cum Plant Head @Biomax Biotechnics Private Limited

Chandigarh, IN

I have 25+ years’ experience in Pharma companies i.e. Dosage formulation / API section/Fermentation, Ayurvedic/Cosmetic/ Nutraceuticals looking for Plant management system, New Project installation & functional (Beta, Cepha & Non-Betalactum section)*Soft gelatin Mfg. System*,*Sterile (Liquid & Dry powder injection) 12+ years experience for Mfg. & QMS approach*, Control of sales/Purchase & finance, deta reviewed - QA / QC/ Production - Data integrity, Software MARG, ERP, SAP, Validations, QMS, CFT, QBD, QRM, Vendor API system, OOS, OOT, Change Control, Deviation, Investigation-CAPA, ACTD-CTD Dossiers & Regulatory Audits, Risk assessments (QRM), Technology transfers, Dossiers(ACTD & CTD), Product license-FDA, COPP license-Export, APQR-Monthly review, Validation system, QC compliance(Schedule-L1)WHO–Unit Approval (individual), Water system, HVAC system(Contamination) & Critical Market complaint. Approved in Analytical chemist (CIM) by Drug Authority(H.P, Haryana & Telangana), Team /Doc. management, Process yield & cost effectiveness, Vendor management-RM/PM/QC chemical, QMS, QBD, QRM, Work on Basics of Quality Assurance (GCECGCI),Drug regulatory affair, Clinical research, Contract Manufacturing – LL, P2P based, facility Qualification, Handling of 250 +staff of QA/QC/Production (General, Cepha & Betalactum facility) & RM-API vendor management i.e. CMS/CMO, Contract Manufacturing system. Handling & Planning for international Audits (General GMP audit or Product specific audit) of almost all major regulatory agencies like USFDA (06 – Times individually), TGA (04-times), MHRA(02-times), EU(05-times), WHO(12-times), Japan (02-times), ISO–9001(Quality), ISO–14001(Environment).Annual target of quality improvement with zero complaint (batch scanning with optical inspections, Training/Learning management system. Analytical method transfer system (R&D, LL system, Quality trend analysis through CAPA, APQR, MFR, Water, EM, QMS, Critical recall, market complaint,

Veer Bahadur singh Purvanchal university, Jaunpur.

Master's degree (M.Sc.), Organic chemistry (Drug Special)

V.B.S Purvanchal University

Doctor of Philosophy - PhD, Anti-Microbial Compounds

V.B.S Purvanchal University

Doctor of Philosophy (Ph.D.), Antimicrobial compounds (Organic Chem.)

V.B.S. purvanchal university, Jaunpur. UP.

Bachelor's degree, Chemistry, Zoology, Botany.

Shibli national school, azamgarh. up.

intermediate, Science stream

BII institute, Noida, Ghaziabad.

Pharma regulatory Affairs, Regulatory affairs, clinical reserch, Pharmacology, Pharmacovigilance