Quality Assurance Senior Expert – Fill & Finishing
Job Description
A global pharmaceutical company is seeking a Quality Assurance Senior Expert to provide support within the Quality Ops organization, particularly for the implementation of a new Fill and Finishing and Visual Inspection area. This role may also involve routine GMP operations in the Fill and Finishing area. The successful candidate will ensure the quality of information reported within various systems and documentation, adhering to current guidelines, compliance, and regulatory requirements. In this role, you will prepare, evaluate, and approve controlled documentation, review deviations within production quality systems (e.g., Trackwise), conduct or approve investigations and impact assessments, define relevant CAPAs, approve on-floor aseptic interventions during Aseptic Process Simulations, review Master Batch Records, and ensure completion of relevant training and software access management according to company policies. You will also participate in meetings relevant to these tasks and support additional quality oversight activities as needed, including continuous improvement initiatives and GMP tours.
Essential Requirements
· Academic technical and scientific education (Bac +5)
· 2–3 years of operational cGMP experience in a Quality Ops department at a sterile injectable pharmaceutical production site
· Holistic knowledge of production processes: unit operations, equipment, gowning, environmental controls, physico-chemical and biological lab tests
· Knowledge of Quality frameworks (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation, etc.)
· Strong writing skills for documentation in French and/or English
· Languages: French and English
· PC proficiency, including Microsoft Office applications
· Ability to work in a team
· Agility and autonomy
Preferred Requirements
· Experience with aseptic process simulations and Fill and Finishing operations
· Ability to interact with Manufacturing, Engineering, Sterility Assurance, Quality Ops, and Training teams
Practicalities
Start Date: Position 1 – ASAP or 02/03/2026 to 30/09/2026 | Position 2 – ASAP or 01/04/2026 to 30/09/2026
Location: Neuchâtel, Switzerland
Team: Reporting to QA Manager, with daily interactions across multiple departments
Scope: Site-based support with minimum 4 days on site; work in two shifts (2×8) is expected for a few weeks during the assignment to support aseptic process simulation activities: