Sidney Gong Email & Phone Number

A highly motivated, goal-oriented Quality Professional, with over 18 years of hands-on experience in GMPs, Quality Management Systems and Analytical Laboratory of regulated industries. Exceptionally organized and disciplined, armed with well-developed interpersonal skills and proven ability to motivate in a leadership role. Analytical problem solver, skilled in extensive quality systems, supplier quality management, and regulatory and compliance auditing experience.Auditing Expertise: ICH Q7, 21 CFR 210&211, 110, 111, 117, 121, 700 and 820, ISO22716, HACCP, BRC CP3&4Qualification Profile▪ ASQ Certified Quality Auditor (CQA), membership of ASQ and ISPE ▪ Qualified senior GMP lead auditor for pharmaceutical (e.g., OTC drugs, API, and intermediates), dietary supplement, food, cosmetic, and medical device▪ Certified GRMA Auditor for OTC Drugs, Dietary Supplements, Cosmetics) under GRMA schemes against NSF/ANSI 455 standards▪ Certified ISO13458 lead auditor, ISO22716 lead auditor, BRC lead auditor and BRC Approved Training Partner (trainer) for consumer products▪ Trained and qualified PCQI (Preventive Control Qualified Individual) and FDQI (Food Defense Qualified Individual) for Human Food▪ Field audit experiences in pharmaceuticals (including OTC drugs, API and intermediates), dietary supplement, food, cosmetic, and medical device▪ Analytical skills with the ability to visualize, articulate, and solve complex problems and make decisions based on available information and determine appropriate resolutions▪ Requisite expertise in maintenance and improvement of quality systems and laboratory management systems▪ Hands-on experience in execution and operations of various laboratory instruments including HPLC, GC, FTIR, AAS, UV/ fluorescence spectrophotometer, fluorescence microscope, etc., and laboratory analytical methods in various pharmacopeia such as USP, FCC, BP, EP, JP and CP

Listed skills include Gmp, Quality Assurance, Pharmaceutical Industry, Quality System, and 26 others.