David Jasek

SENIOR CONSULTANT

10 years of GMP Quality expertise supporting the manufacture, release and distribution of IMP, Drug Substance and Drug Product, with a focus on Quality System design and remediation.

About David

David is an expert in quality, with over 10 years of experience across multiple regulatory jurisdictions within the pharmaceutical industry. David joined Dark Horse in 2021 as a Senior Consultant, bringing experience in testing and commercial manufacture of API, IMP, and Drug Products as well as quality system design and implementation, validation, vendor management, inspection preparation, and remediation activities.

David’s previous non-quality roles span GMP production and distribution, including supervising the manufacture of growth media to support mycoplasma vaccine manufacture, sterile production and filling operations, and management of a pharmaceutical distribution center.

David transitioned into quality roles in 2011, initially focusing on product complaints and investigations before moving into broader quality system design and continuous improvement activities in 21 CFR regulated environments.

In 2015, David relocated from Australia to the UK and supervised QMS activities at a large remote certification site. In addition to system design and reporting, David was also involved in and led oversight of the data migration and CSV of new electronic quality system and general systems integration between multiple large EU sites.

David’s next role was as a Quality Manager at an IMP manufacturer and contract testing site. The key responsibilities for this role included management of all client audits and responses, review and batch release of all IMP material and supporting clients during regulatory submissions. The role also included oversight of all quality activities, including raw material and release testing, stability study review and approval, equipment qualification as well as vendor review and approval.

In 2019 David moved to a quality role at an API manufacturing site. In addition to involvement in quality system activity and the release and certification of API, David designed and implemented the Data Integrity assessment and remediation system across the site, ensuring compliance with the most recent MHRA, EMA and FDA guidance and industry best practices.

EXAMPLES OF RECENT WORK

  • Development and implementation of site-wide Data Integrity system
  • Quality Audit of microbiological testing vendor to support GMP manufacture
  • Quality representative on multiple, concurrent clinical API manufacturing projects, responsible for ongoing compliance as well as batch review, release and certification.

PAST EXPERIENCE

Pharmaron
Associate Principal QA Advisor

Intertek Melbourn
Quality Assurance Manager

Pfizer
Senior Quality Assurance Officer

Hospira
Senior Quality Assurance Officer
Quality Assurance Officer

PCCA
East Coast Distribution Center Manager
Quality Assurance Supervisor
Senior Quality Assurance Auditor
Quality Assurance Auditor

Bioproperties Pty Ltd
Media and Filling Supervisor
Media Laboratory Supervisor
Laboratory Technician

EDUCATION

University of Technology Sydney
BSc. Chemistry

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