Job Description
Ideally, we are looking for a candidate with auditing experience in the clinical research field, but candidates with clinical research experience (site perspective) or auditors in different fields can also apply.
Your responsibilities:
As Quality Assurance Auditor you are welcomed in a smaller, amiable, and enthusiastic QA team where you will have day-to-day interaction with other QA experts in the field, such as other Auditors, Quality Compliance Managers, Operational Quality Managers, …
You contribute to the effectiveness of the SGS Quality Management System by conducting internal audits within the different operational teams, and by contributing to the vendor qualification process in collaboration with the operational and contract teams. In addition, you conduct contract audits (mostly site audits) on behalf of our clients.
Your main responsibilities are the following:
1. Plan, conduct and report internal audits, to assure that the SGS quality system remains up to date and that services are performed in accordance with relevant requirements (clinical study protocol, contract, GxP, Standard Operating Procedures (SOPs) and applicable regulatory requirements). This includes system, project, computerized system validation, and ISO 27001 audits.
2. Plan, conduct and report vendor assessments, to assure the suitability of a vendor (subcontractor) for performing a certain service or providing a certain product, and to assure vendor’s compliance with GxP, applicable SOPs and regulatory requirements. These vendor assessments include vendor questionnaires and vendor audits, which can be onsite or remote. Via the vendor qualification process you will encounter a wide variety of vendors, ranging from courier services, over different (specialty) labs, to storage facilities and SaaS providers.
3. Plan, conduct and report contract audits on behalf of our clients. These are mainly focused on GCP and are mostly site and study (including eTMF and CSR) audits, or vendor qualification audits.
4. Participate in the yearly vendor evaluation.
5. Participate in additional team initiatives, like development of training material, providing training related to the quality management system and quality awareness, identify process improvement opportunities, foster a culture of quality, and provide advice / expertise on questions from colleagues (GxP, CSV, data integrity, …).
Qualifications
What do you need to be succesful in this role?
6. You have a university degree in sciences, a (para)medical area or pharmaceutical sciences. An equally recognized degree and/or relevant qualifications by experience may also be acceptable.
7. You have at least 3 years of clinical research or auditing experience in an industry setting.
8. Quality management system experience in a GxP environment is an advantage. In addition, GCP experience in an investigator site environment is considered a significant asset. Also considered to be an asset, is experience with / knowledge about computerized system validation.
9. You are fluent in English. Knowledge of Dutch is a plus.
10. You have good observing capacities, a critical mindset and are an easy learner, with a sense of responsibility, integrity, diplomacy, and confidentiality. You have good planning and organizational skills.
11. You have a strong affinity with (inter)national guidelines and regulations related to clinical research and can make decisions based on appropriate interpretations.
12. You have a sense of structure, precision, analysis, synthesis, and prioritization.
13. You are a team as well as individual player.
14. You are flexible and prepared to commit to international travel up to a maximum of 30%.