dettagli di lavoro
For one of our clients, an international pharmaceutical company in the canton of Neuchâtel, we are looking for a
Technicien Specialist QA Validation & QC
Contract: Contractor (long term)
This role offers a unique opportunity to contribute to the quality and compliance of pharmaceutical manufacturing processes within a dynamic and growing organization.
Tasks:
Your responsibilities include, but are not limited to:
- Quality monitoring, deviation follow-up, investigations, management of OOS, CAPA and Change Management.
- Quality control expertise: OOS, OOT, OOE, method validation/transfer and pharmacopeial surveillance.
- Review and approval of IT periodic reviews and validation periodic reviews related to computerized and automated systems, as well as data integrity events.
- Active participation as QA representative in site expansion projects.
- Review and approval of qualification and validation documentation (DQ, IQ, OQ, PQ, UAT, cleaning validation, process validation).
- Participation in project management teams for the development and integration of business applications (LIMS, MES, SAP, OSI-PI).
- Review and approval of data integrity assessments for new and existing systems.
- Support QC/QA transfers of new products/methods to the Switzerland site.
- Drafting, reviewing and recommending operating procedures and quality documents.
- Support for the design of GMBR.
- Participation in risk assessments and brainstorming sessions on quality issues.
- Support for QA Operations sales team.
- Support and supervision of other departments and functions on data integrity issues.
- Support and supervision of the QC department, identification, and management of QC and GMP compliance issues.
- Participation in the preparation and support of authority inspections (various roles).
Your profile:
- Min. 3 years' experience in QC and/or QA in a pharmaceutical company or related sector, ideally with experience in computerized systems validation and project management.
- BSc/BA or MSc in Science or a relevant discipline
- Thorough understanding of GMP and Swiss, European and FDA regulatory requirements - Knowledge of GAMP a plus
- Intermediate knowledge of health authority regulations concerning data integrity, data management and Part 11 / Annex 11 compliance.
- Good understanding of OSD packaging and warehousing, or bulk and QC.
- Excellent team spirit.
- Ability to manage multiple projects in a stressful and dynamic environment.
- Fluency in French and English required
For one of our clients, an international pharmaceutical company in the canton of Neuchâtel, we are looking for a
Technicien Specialist QA Validation & QC
Contract: Contractor (long term)
This role offers a unique opportunity to contribute to the quality and compliance of pharmaceutical manufacturing processes within a dynamic and growing organization.
Tasks:
Your responsibilities include, but are not limited to:
- Quality monitoring, deviation follow-up, investigations, management of OOS, CAPA and Change Management.
- Quality control expertise: OOS, OOT, OOE, method validation/transfer and pharmacopeial surveillance.
- Review and approval of IT periodic reviews and validation periodic reviews related to computerized and automated systems, as well as data integrity events.
- Active participation as QA representative in site expansion projects.
- Review and approval of qualification and validation documentation (DQ, IQ, OQ, PQ, UAT, cleaning validation, process validation).
- Participation in project management teams for the development and integration of business applications (LIMS, MES, SAP, OSI-PI).
- Review and approval of data integrity assessments for new and existing systems.
- Support QC/QA transfers of new products/methods to the Switzerland site.
- Drafting, reviewing and recommending operating procedures and quality documents.
- Support for the design of GMBR.
- Participation in risk assessments and brainstorming sessions on quality issues.
- Support for QA Operations sales team.
- Support and supervision of other departments and functions on data integrity issues.
- Support and supervision of the QC department, identification, and management of QC and GMP compliance issues.
- Participation in the preparation and support of authority inspections (various roles).
Your profile:
- Min. 3 years' experience in QC and/or QA in a pharmaceutical company or related sector, ideally with experience in computerized systems validation and project management.
- BSc/BA or MSc in Science or a relevant discipline
- Thorough understanding of GMP and Swiss, European and FDA regulatory requirements - Knowledge of GAMP a plus
- Intermediate knowledge of health authority regulations concerning data integrity, data management and Part 11 / Annex 11 compliance.
- Good understanding of OSD packaging and warehousing, or bulk and QC.
- Excellent team spirit.
- Ability to manage multiple projects in a stressful and dynamic environment.
- Fluency in French and English required
Condividi questa opportunità
