Quality Assurance Specialist
Vor 3 Tagen
For our client, an international company based in Neuchâtel, we are looking for a Quality Assurance Specialist.
The objective of this role within the Quality Ops organization is to provide support as a Quality Assurance Specialist in the frame of 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.
General Information:
- Start date: ASAP
- End date: 31.12.2024
- Workplace: Neuchâtel
- Workload: 100%
- Home office: possible, max. 1 day per week
Tasks and responsibilities:
- 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.
- Prepare, evaluate, and approve controlled documentation revision
- 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 the company 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.)
Your profile:
- Technical and scientific academic training
- 2-3 cGMP operational experiences in a Quality Ops department on a Pharmaceutical production site of sterile injectable products.
- Holistic knowledge of production processes (from cell culture to aseptic distribution): unit stages, equipment, gowning, environmental controls, physicochemical and biological laboratory tests, etc.
- Knowledge of Quality standards (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation, etc.)
- Writing ability for documents in French and/or English
- Languages: French and English fluent
- Work on PC and Microsoft pack knowledge
- Team work
- Agility and autonomy
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