On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a Lead Investigator, Quality Control
- Duties and Responsibilities
Lead Investigator for QC deviations:
- Act as Deviation Owner and Lead Investigator for QC deviations requiring a formal root cause analysis.
- 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.
The Lead Investigator will join the QC Business Enabling and Support team of the Quality Control (QC) department of Celgene/BMS in Boudry, Switzerland. The QC department is responsible for testing raw materials, drug substance (API), drug product (Bulk) and stability samples for oral solid dosage forms.
This position is primarily responsible for managing QC deviations, performing formal root cause analysis, and defining effective corrective and preventive actions (CAPAs).
- Skills/Knowledge Required
- 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)