Consultant, Pharma Biotech

Email: pharmamail@nsf.org
Phone: +44(0)1751 432999
Country: United Kingdom

Samantha Clack is a quality consultant and Qualified Person with over 20 years of experience in technical, quality and managerial roles in parenteral, solid dose and topical dosage form manufacture.  She is an ISO Lead Auditor and also the trainee QP coordinator and secretary for the Pharmaceutical Quality Group (PQG).

She started her career with Patheon Ltd (formerly Hoechst Marion Roussel) in Swindon, where she worked in technical and managerial roles in manufacturing and packaging. With Patheon she gained experience in a wide range of dosage forms including sterile powder filling, sterile and non-sterile ointment filling, creams, liquids and suppository manufacture and filling, tableting and packaging.

She next worked for Eli Lilly & Company Limited as a senior quality assurance associate in the Corporate Quality Assurance division. Her responsibilities included auditing Lilly’s third-party contractors and suppliers covering parenteral, biotech, liquids and creams, solid dose and API dosage forms as well as excipients, warehousing, marketing affiliates and clinical trial sites. The role also involved providing training in quality management systems for Lilly affiliates worldwide.

Ms. Clack then joined Eisai Manufacturing Limited as QA Manager of Marketed Products, concentrating on the start-up of a new solid dose manufacturing and packaging facility, implementing and developing quality systems and processes as well as performing batch disposition activities for products manufactured at contract manufacturers. She played a key role in the management of regulatory inspections, cumulating in the site gaining its full manufacturing license.

Her recognized areas of expertise include:

  • Microbiology
  • Solid dose and sterile product manufacture and packaging
  • Quality management systems
  • Qualified Persons training
  • Auditing of excipient, API, finished dosage form and primary and secondary packaging facilities worldwide
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