- Region Neuchâtel
- Type of contract Temporaire - Temps plein
- Sector of activity Pharmaceutique / Biotechnologies / Chimie
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
This position is primarily responsible for managing QC deviations, performing formal root cause analysis, and defining effective corrective and preventive actions
Description of the 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
Required profile
- 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)
Information
- Agency INTERIMAN - LAUSANNE
- Published on 20 février 2023
- ConsultantBernadette KEHL
