QA Engineering/Validation Expert
job details
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:
This resource will be specifically responsible for the following tasks:
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
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
- Languages: French and English
- PC work and Microsoft pack knowledge
- Team work
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:
This resource will be specifically responsible for the following tasks:
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
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
- Languages: French and English
- PC work and Microsoft pack knowledge
- Team work
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