sr qa analyst
- Date de publication
Our client is looking for a
Senior QA Analyst
Location: Neuchatel, Switzerland
Contract: 1 year with possibility of extension
Start date: as soon as possible
- Maintain and continously improve the quality management system to support clinical studies and to ensure compliance with Good Clinical Practice (GCP) and local regulatory requirements
- Develop audit plans to ensure all clinical trials are conducted in compliance with the study protocol, site procedures, and all applicable regulatory requirements.
- Conduct audits of clinical sites, clinical quality systems, clinical vendors, sponsor and regulatory documents to ensure clinical trials are conducted per Good Clinical Practice (GCP) requirements.
- Assists in the development of metric reports to QA management of all issues related to the outcome of the audits.
- Support the establishment and maintenance of the QMS AND quality standards, to assess compliance with GxP principles and internal PMI R&D QMS.
- Verify and support GxP compliance of computerized system validation and change control according to established regulations and guidelines such as GAMP5 and 21CFR11.
- Create and advise on and support the establishment and continual improvement of Standard Operating Procedures and Work Instructions.
- Remain up-to-date with the evolution of the regulatory framework concerning GxP principles and other relevant quality standards.
- Master’s degree in Engineering or Life Sciences
- Substantial practical experience in quality assurance within a GxP industrial environment such as Pharmaceuticals, Medical Devices, Biotech or Food
- Excellent working knowledge/understanding of International Conference on Harmonization (ICH) Q8, Q9, Q10 and of GCP-related requirements.
- Proficiency in US regulations and ICH guidelines for the conduct of clinical trials.
- Experience in conducting audits and in working on audit report submission and follow up.
- If you also possess a clinical development background, will be a plus
- Strong customer focus, communication, presentation and interpersonal skills, to ensure cross-functional collaboration internally and to be the PMI representative to external Partners.
- Flexible and can travel internationally up to 50%.
- Fluent in both written / spoken English (proficiency in French would be an asset).