GxP Compliance Specialist – Quality Control m/w/d
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1800 Vevey, Schweiz |
Temporary Employment
Project title: GxP Compliance Specialist – Quality Control m/w/d
Type of employment: Payroll
Industry: Biotech
Skills: Quality Control,Deviation management
Project start: January 2026
Project duration: 6 months
Location: 1800 Vevey, Schweiz
Tasks:
- Support the QC team in their daily operations as an expert of compliance aspects for QC.
- Manage, investigate and close events and deviations in support of Subject Matter Experts in QC.
- Contribute to the data review process according to the established quality requirements.
- Manage and support the timely and effective completion of deviations, non-conformances, investigations, change controls, and CAPAs; perform period reviews.
- Continuously improve data integrity (DI) knowledge base, including DI risk-analysis assessments and action plans, and periodically report status/progress to leadership team.
- Author, review, approve and maintain life cycle of relevant Standard Operating Procedures, Work Instructions, and all other quality documents related to areas of responsibility, as well as support other areas as required.
- Contribute to the assessment of regulatory and pharmacopoeia updates linked to QC activities.
- Support preparation of audits and interact directly with internal HCQ auditors and external regulatory agencies.
- Recommend and drive improvements to existing systems, processes, techniques or programs.
- Manage training plans of the team and support in ensuring training compliance.
- Collaborate with cross-functional teams, in particular act as Singe Point of Contact to QA, to address compliance issues and implement corrective actions.
- Provide training and guidance to staff on GxP regulations and best practices.
- Stay updated on industry regulations and trends to ensure continuous compliance.
Qualifications:
- Practical experience working in a in QC lab.
- Experience with Quality Systems such as Deviation, CAPA, Change control.
- Strong knowledge of GLP/GMP/Quality System requirements and international guidelines (e.g. ICH, FDA, EMA) for biopharmaceuticals; knowledge of Data generation, Data processing, Data Quality principles.
- Excellent investigational and problem-solving skills. Ability to interpret complex situations and to articulate recommendations for issue resolution.
- Previous direct experience in audits and interactions with health authorities.
- Preferred hands-on experience with laboratory information systems, digital tools, automation technologies and lean principles.
- You are fluent in English (B2 or higher), French is a plus.
Referenznummer: 16869
Branche: Biotech
Beginn des Projekts: January 2026
Dauer: 6 months
Anstellungsart: Temporary Employment
Kontakt
Tünde Verebélyi