Jobdescription For our client, an international pharmaceutical company based in Neuchatel, we are looking for a QA Engineering/Validation Expert. Background 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. General information:
Start date: asap
Planned duration of employment: 8 months
Workplace: Neuchatel
Workload: 100%
Working hours: standard
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 Takeda 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.)
The above-mentioned tasks are site-based, an on-site presence is expected. Home office might be allowed occasionally for specific tasks upon request. 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