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Quality Control Lead Investigator

Ref: JN-022023-400996

Publié le 15 February 2023
Sciences de la vie

For a leader in the pharmaceutical industry, opportunity of minimum 15 months as  Quality Control Lead Investigator. 

Your Role:

  • Act as Deviation Owner and Lead Investigator for QC deviations requiring a formal root cause analysis.
  • Enable and Support team of the Quality Control (QC) department responsible for testing raw materials, drug substance (API), drug product (Bulk) and stability samples for oral solid dosage forms.
  • Work cross-functionally with impacted areas to define appropriate and effective corrective and preventive actions.
  • Ensure timely and compliant closure of laboratory root cause investigations, QC deviations and CAPAs.
  • Timely and appropriately escalate issues requiring management decision and impacting resource allocation. Fill and maintain dashboards, KPIs.
  • Communicate effectively with QC management, quality management and cross-functional teams such as Manufacturing Science and Technology, Analytical Science and technology, Quality Assurance.
  • Present QC deviations and investigation findings at Quality governance forums and in audits conducted by regulatory agency representatives.
  • Authors, reviews, and approves complex GMP documentation such as standard procedures, work practices, training plans, protocols, and reports.
  • Perform other tasks as assigned.

Your Qualifications:

  • BSc degree in Life Sciences, Chemistry, or relevant technical discipline.
  • 3 years of work experience in a QC environment in the pharmaceutical industry
  • An equivalent combination of education and experience
  • Ability to take a structured and analytical approach to problem solving. Experienced with root cause analysis tools and methodologies.
  • Excellent scientific knowledge and hands-on experience of analytical techniques such as liquid and gas chromatography, dissolution, spectrometry, and Karl Fisher.
  • Good knowledge and interpretation of cGMP and Pharmacopeia requirements
  • Experience of analytical testing according to Ph. Eur. and USP requirements.
  • General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
  • Effective verbal communication skills, ability to interact with different levels of the organization: manager, peers, lab analysts, and other departments
  • Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports) as well as deviations and investigations.
  • Ability to work collaboratively and cross-functionally.
  • Capability to work with short deadlines and simultaneous activities
  • Fluent in English or French and professional command of the second language (written and verbal)