QA Expert Senior

Manpower

For our pharmaceutical client located in Neuchatel, we are seeking QA Expert with experience in routine GMP operations within the Fill & Finish area.

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 involved 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.

• 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.
• Approve on the floor aseptic interventions performed by manufacturing during Aseptic Process Simulation.
• Review Master Batch Records.
• Respect the escalation process.
• Ensure completion of relevant training and software access management according to Takeda 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, etc.).

The above-mentioned tasks are site-based and on-site presence is expected. Home office might be allowed occasionally for specific tasks upon request.

• Technical and scientific academic background (Master's degree / Bac +5)
• 2–3 operational experiences in cGMP within a Quality Operations department on a pharmaceutical manufacturing site producing sterile injectable products
• Holistic knowledge 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 documents in French and/or English
• Languages:
  
  French and English
• Computer skills and knowledge of the Microsoft Office suite
• Teamwork skills
• Agility and autonomy

• Minimum of 4 days on site
• Reporting to the QA Manager, with daily interactions with Manufacturing, Engineering, Sterility Assurance, Quality Operations, Training, etc.
• 2-shift (2×8) schedule to be expected during aseptic simulation tests

• A 2×8 shift schedule will be required for several weeks during the assignment to support aseptic process simulation activities:
  • 06:00 – 14:30
  • 14:00 – 20:30

If you are interested, please apply with a copy of your CV at the earliest. This job will halt to accept applications end of January. Interviews will be online and 2 rounds.

Settore:
Industria farmaceutica
Ruolo:
Risorse umane