Quality Control Lead Investigator

View: 141

Update day: 03-04-2024

Location: Neuchâtel Neuchâtel NE

Category: R & D

Industry: Pharmaceutical Manufacturing

Position: Associate

Job type: Full-time

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Job content

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

Your Responsibilities

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)

#Boost

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