QC Scientist

Actalent; Neuenburg; Presencial; CHF 90.000 - 120.000; Jornada completa

Descripción de la vacante

Actalent in Neuchâtel, Switzerland is seeking a Scientist to oversee lifecycle management of analytical assays in the QC Laboratories, focusing on Laboratory Investigations, Critical Material Qualification and Method Transfers.

You will author transfer protocols and qualification reports, lead validation activities and support quality control with regulatory standards. Fluent in English and French, starting ASAP for a temporary contract through August 2027.

Formación

• Requires GMP pharma experience or exposure.
• Knowledge of method transfer and critical reagent qualification preferred.
• Fluent in French and English (C1 written and spoken).

Responsabilidades

• Author transfer protocols and reports for assays.
• Author qualification plans and reports for critical reagents.
• Oversee validation and qualification activities and provide training/support.
• Execute and document experiments.
• Investigate and troubleshoot problems; perform risk assessments and CAPAs.
• Own Laboratory Investigations and CAPA.
• Support regulatory compliance and provide technical/statistical input.

Conocimientos

Fluent in French and English (C1)

Educación

University or engineering degree in analytical chemistry/biotechnology/biochemistry

Descripción del empleo

For our client based in Neuchâtel (Switzerland), we are looking for a Scientist to be accountable for life cycle management activities of analytical assays performed in the QC Laboratories of Neuchâtel, with a focus on Laboratory Investigations, Critical Material Qualification and Method Transfers.

Responsibilities

Validation and Qualification Activities

• Author transfer protocols and reports for assays
• Author qualification plans and reports for critical reagents
• Oversee validation and qualification activities executed by analysts, provide training and support
• Execute and documents experiments

Investigation Leads

• Investigate and trouble shoot problems which occur to determine solutions or recommendations for improvements or change
• Conduct/participate in risk assessments, root cause analysis and investigations
• Own Laboratory Investigations and CAPA

Quality Control Support Activities

• Support the application of industry specific compliance standards/regulations to
• Participate to daily activities upon request (provide technical and statistical support)

Requirements

• University or engineering degree in analytical chemistry, biotechnology, biochemistry
• 1 or 2 years of experience in GMP pharma business activities, preferably in the scope of recombinant therapeutic product in pharmaceutical environment
• Experience in GMP Laboratory activities
• Good knowledge of method transfer and critical reagent qualification
• Fluent in French and English (C1 written and spoken)

Contract: Temporary – until August 2027

Start Date: ASAP

While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.