R&D QA Manager in Oakville at Apex Life Sciences

Date Posted: 2/9/2018

Job Snapshot

Job Description


Quality System Manager

Apex Life Sciences is searching for a Quality System Manager for a permanent role in one of our client companies. Our client is a pharmaceutical company based in the Burlington, ON area. This position would be responsible for overseeing all quality related activities that support development, technology transfer and cGMP manufacturing of drug products for submission to the FDA and Health Canada.

This position would be working to support the research and development team as well as manufacturing.


Responsibilities:

  • Review and approve C of A's and analytical reports for submission.
  • Review and approve master production documents.
  • Review and approve Validation plans and protocols.
  • Review finished product specifications. 
  • Review and manage the translation of CMC documentation.
  • Review and approve analytical method validation and method transfer reports and protocols.
  • Lead deviation investigations 
  • Review and approve lab investigation reports
  • Review and approve stability protocols
  • Review proposed artworkl 
  • Review and manage execution of Quality Agreements with API suppliers and CMO sites of products under development
  • Manage mock Pre-Approval Inspections (PAIs) that includes audits, gap analysis and addressing gaps with CMO and API sites.
  • Support R&D team on quality system responsibilities
  • Conducts internal audits.

Job Requirements:

  • BSc in Chemistry or Life Sciences discipline
  • 5-10 years of experience in the pharmaceutical industry in the areas of R&D, R&D QA, Process Validation management and/or Product Launch
  • Experience working with pharmaceutical quality systems.
  • Project management skills
  • Experience with US-FDA and Health Canada
  • Independent worker
  • Excellent communication skills
  • Excellent computer skills.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.