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QA Expert (M/F/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 requirements.
This resource will be specifically responsible for the following tasks:
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.
Attend all meetings relevant to perform the above-mentioned tasks.
Respect the escalation process.
Ensure completion of relevant training and software access management according to 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:
Technical and scientific academic background (Master’s degree – Bac +5)
2–3 years of operational cGMP experience in a Quality Operations department within a pharmaceutical production site for sterile injectable products.
Holistic knowledge of production processes (from cell culture to aseptic filling): unit operations, equipment, gowning, environmental controls, physicochemical and biological laboratory testing, etc.
Knowledge of Quality guidelines (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation, etc.)
Strong writing skills for documents in French and/or English
Languages: French and English
Proficiency in PC usage and Microsoft Office suite
Teamwork skills
Agility and autonomy
Work mode: Minimum of 4 days on-site
Reporting to the QA Manager, with daily interactions with Manufacturing, Engineering, Sterility Assurance, Quality Operations, Training, etc.
Requirements:
Start: asap
Duration: 31.05.2025 + possibility to extend
Capacity: 5 days per week
Location: Greater Neuchatel Area
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