Senior QA Specialist

K-Recruiting Life Sciences; Neuenburg; Vor Ort; CHF 80’000 - 100’000; Vollzeit

Zusammenfassung

A leading life sciences recruitment agency is seeking a Senior QA Specialist in Neuchatel, Switzerland. The role involves ensuring quality assurance in a pharmaceutical manufacturing environment, specializing in sterile injectable products. Candidates need a Master's degree and at least 2-3 years of cGMP experience. Fluency in French and English is required. This 6-month position offers a capacity of 5 days per week.

Qualifikationen

• Minimum 2–3 years of operational cGMP experience in Quality Operations.
• Familiarity with documentation systems and regulatory requirements.
• Experience in pharmaceutical manufacturing processes.

Aufgaben

• Provide support as a Quality Assurance Senior Expert.
• Ensure quality of information reported in various systems.
• Review deviations and conduct investigations related to production events.

Kenntnisse

Operational cGMP experience

Strong writing skills

Knowledge of Quality standards

Holistic understanding of production processes

Language proficiency in French and English

Ausbildung

Master’s degree or equivalent

Jobbeschreibung

Senior QA specialist (M/W/D)

Tasks:

• The objective of this resource within the Quality Ops organization is to provide support as a Quality Assurance Senior Expert in the frame of implementation of a new Fill and Finishing and Visual Inspection area
• He/she could also be involve in routine GMP operations for Fill and Finishing area
• He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirement
• Prepare, evaluate, and approve controlled documentation, creation/revision.
• Review of deviations in the framework of production events within quality systems (i.e. Trackwise) to verify acceptability and adherence to standard procedures and regulatory requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of relevant CAPA.
• Ensure completion of relevant training and software access management according to company´s policies
• Other tasks related to conventional quality oversight might be occasionally requested to support the team (e.g. continuous improvement initiatives, GMP tour in classified areas, batch review, etc.).

Qualification:

• Academic background in a technical and scientific field (Master’s degree or equivalent – Bac +5)
• 2–3 years of operational cGMP experience in a Quality Operations department at a pharmaceutical manufacturing site producing sterile injectable products
• Holistic understanding of production processes (from cell culture to aseptic filling): unit operations, equipment, gowning, environmental monitoring, physicochemical and biological laboratory testing, etc.
• Knowledge of Quality standards (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation, etc.)
• Strong writing skills for drafting documents in French and/or English
• Languages: French and English
• Minimum 4 days on-site
• Reporting to the QA Manager, with daily interaction with Manufacturing, Engineering, Sterility Assurance, Quality Operations, Training, etc.

Requirements:

Start: 01.08.2025

Duration: 6 months

Capacity: 5 days per week

Location: Neuchatel, Switzerland