Lead Investigator

**INTRODUCTION**:
For our client, a leading international Pharma company, we are searching for a:
**Lead Investigator & Quality Control H/F - 100% - 15 months temporary contract**

This position is primarily responsible for managing QC deviations, performing formal root cause analysis, and defining effective corrective and preventive actions

**DESCRIPTION DE LA MISSION**:

- Act as Deviation Owner and Lead Investigator for 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, corrective and preventive action
- Timely and appropriately escalate issues requiring management decision and impacting resource allocation. Fill and maintain dashboards, KPIs
- Communicate effectively with management, quality management and cross-functional teams such as Manufacturing Science and Technology, Analytical Science and technology, Quality Assurance
- Present 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 assignedQC

**PROFIL ATTENDU**:

- BSc degree in Life Sciences, Chemistry, or relevant technical discipline
- 3 years of work experience in a QC environment in the pharmaceutical industry
- 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 European Pharmacopeia and United States Pharmacopeia
- 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)