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