Independent Consultants

Ataqua Regulatory Services employs a flexible workforce of independent consultants (i.e., associates of the company) who may assist ARS as needed based upon project resource requirements and consistent with their individual skills, experience, and area of expertise. All of the ARS’s independent consultants are highly experienced in their respective fields and industries.

Edward Malawer

Edward (Ed) Malawer, PhD has consulted for over a decade as a lead auditor for the USP Verification Programs. He spent the bulk of his career as an analytical chemist mostly with International Specialty Products (ISP), formerly GAF Chemicals, for 28 years, heading its analytical R&D laboratory. At ISP, he supervised the creation and validation of approximately 1500 validated analytical methods and established the process analytical function for the firm. He last served as vice president of analytical R&D, product stewardship and quality assurance at ISP. After establishing a consulting practice in 2007, Dr. Malawer has worked with the USP since 2009 on a contractual basis conducting GMP audits and performing quality control and manufacturing product documentation review for the USP Dietary Supplement Verification Program and the USP Ingredient Verification Programs for dietary ingredients and pharmaceutical excipients. He has been an instructor for both the USP and ACS, e.g., short course on process analytical technology (PAT), and served on the advisory panel for USP general chapter <1197> Good Distribution Practices for Bulk Pharmaceutical Excipients and on the USP’s Povidone Expert Panel. Dr. Malawer published articles on dietary supplement cGMP regulations compliance appearing in the Jan.-Feb. 2014 issue of Pharmaceutical Engineering and in the December 2016 issue of Tablets & Capsules Solid Dose Digest. He holds ten U.S. patents and has authored more than 35 peer-reviewed publications including several textbook chapters. He has received additional, formal drug product cGMP training from ISPE / the GMP Institute.

Education:

  • PhD, Physical Chemistry, New York University
  • BS, Chemistry, City College of the City University of New York

Certifications and Professional Associations:

  • Certified Quality Auditor (CQA), American Society for Quality (ASQ)
Jemma Williams

Jemma Williams is an accomplished GMP quality system consultant with 33 years of experience in quality control and quality assurance with a demonstrated record of achievement in the pharmaceutical, dietary supplement, medical device industries, and compounding pharmacies. Ms. Williams held various managerial roles in quality control and quality assurance for more than 20 years in big pharma prior to providing consulting services over the past 13 years where she has performed remediation activities under the GMP 6 quality systems umbrella. Furthermore, she has implemented GMP quality systems resulting in a sustainable state of compliance for several pharmaceutical companies under regulatory distress, both domestically and internationally, which included addressing Form 483 observations, warning letters and consent decrees. She has consulted for the past 4 years as a lead auditor for the USP Verification Programs.

Education:

  • MBA, Business Administration, University of Phoenix
  • BS, Chemistry, Coppin State University

Certifications and Professional Associations:

  • Certified Quality Auditor (CQA), American Society for Quality (ASQ)

%d bloggers like this: