A progressive, forward-thinking professional in pharmaceutical quality with proven success in managing all aspects of testing, quality systems , manufaturing and personnel. Drive compliance with federal regulations and corporate guidelines at all stages of quality testing and quality systems. Skilled trainer and mentor and able to guide staff in all laboratory,Quality and manufacturing functions.SKILLS• More than 18 years of experience in pharmaceutical Quality Control ( Chemistry, microbiology, Environmental monitoring , Raw Material) Compliance and manufacturing including 7 years of management experience. • Strong knowledge in cGMP, GLP, GXP, USP, EU, 21 CFR, TGA, Data Integrity, Quality systems and change management.• Solid knowledge in CAPAs, Deviations, OOS , OOT, investigations, root cause analysis, customer complaints, internal audits, regulatory agency audits.• Experience in Health Canada, FDA, ICH and USP, BP, ISO regulations • Proficiency in method transfers, new product launches, method development, method validations and equipment qualifications. • Experience in technical quality agreements, recalls, complaints, contract laboratories, supplier qualification, Drug Establish License (DEL) process, Stability management, Annual Product Quality Reviews (APQRs) and 3rd party audits.. Experience CDMO management employing cross-functional collaboration skills.. Hands on experience in solid oral doses, creams, ointments, API, liquid doses, natural products, dietary supplements and cannabis products.• Strong analytical instrumentation skills in HPLC, GC, GC-MS, LC-MS, FTIR, KF, UV-VIS, Dissolution etc..