For our customer located in Neuchatel/Switzerland we are currently looking for a: QA Engineer / Validation Expert (m/f/d)
- Location: CH-Neuchatel
- Branch: Pharma
- Duration: 10.06.2024 – 07.02.2025
Tasks & Responsibilities
Services: The objective of this resource within the Quality Ops organization is to provide support as a Quality Assurance Expert in the frame of routine GMP operations. 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:
- Review deviations in the framework of engineering 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.
- Review and approve Engineering controlled documentation being revised
- Review and approve requalification of Cleaning in place /sterilization in place/ Temperature control unit and review/approve protocol deviations related to.
- Perform the assessment of change control from a Quality Engineering standpoint
- 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 our clients policies
- Other tasks related to conventional quality oversight might be occasionally requested to support the team (e.g. continuous improvement initiatives, GMP tour of technical area, etc.)
Must Haves
Required profile
- Technical and scientific academic training
- 2-3 years of cGMP operational experience in a Quality Ops or Engineering department on a Manufacturing site in the Pharmaceutical Industry, biotechnology and/or sterile injectable products
- Knowledge of Quality standards (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation, etc.)
- Technical knowledge of maintenance, facilities/utilities, HVAC, calibration would be a plus
- Writing ability for documents in French and/or English, and reading documents in French and English
- Languages: French and English
- Work on PC and Microsoft pack knowledge
- Team work
- Agility and autonomy
Work mode:
- Minimum 4 days on site
- Reporting to the QA Engineering manager, but working in daily interaction with Manufacturing, Engineering, Sterility Assurance, Quality Ops, Training, etc.
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.