Senior Quality Assurance Associate

3 weeks ago

Windsor Berkshire, United Kingdom BioTalent Canada Full time

BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.

BIOVECTRA has an opening for Senior Quality Assurance Associate. This is a permanent, full-time position than can be located in Windsor, NS/ Dartmouth, NS.

The candidate will be responsible for:

  • Supporting the incident programs (deviation, laboratory investigation, complaint, supplier etc), including reviewing, assessing the severity and approving minor incidents and participating in the investigations of major incidents.
  • Participating in the internal audit program and leading/supporting external audit requirements.
  • Managing and leading changes to SOPs and supporting changes to SOPs made by other departments through the change control review process.
  • Supporting the APR Program, Metrics and Scorecards Reporting Program, including QSR.
  • Monitoring and enforcement of GMP requirements during day to day operations for all departments within the company.
  • Supporting the supplier management program, with particular focus on the management of supplier change notifications.
  • Inspecting and releasing rooms and performing facility inspections as part of general compliance activities.
  • Preparing or assisting in the preparation of reports and protocols, including validation and qualification.
  • Providing GMP and SOP training to various departments.
  • Supporting the CAPA program.
  • Supporting Process lifecycle by reviewing and approving creation and changes to batch records.
  • Participating in document lifecycle activities of SOPs, and QA review and approval of SOP changes.
  • Adhering to BIOVECTRA’s Health and Safety Policy as outlined in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities.
  • Additional duties assigned, based on business needs and the department supervisor’s request.

The successful candidate for this position should have:

  • Post-Secondary Education.
  • Bachelor’s degree in a scientific field an asset.
  • Three years of work experience with a food or drug manufacturing company, with one year direct experience in a Quality Unit position.
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