Quality Assurance Auditor
il y a 1 mois
**Company Description** At SGS, you can choose.**
First of all, out of our various vacancies.
However, SGS also gives you another choice.
Do you choose to _expand_ or to _enrich_? We are not only looking for _colleagues who can go into depths of their discipline_. We are equally as much looking for _colleagues who we call ‘connectors’, people who can connect our diversity to our services_. To each other. And this way, enrich our business.
SGS is the world’s leading inspection, verification, testing and certification company. We’re also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to almost 100 000 colleagues worldwide, with more than 1650 employees in Belgium only. Our employees give 110% of themselves every day, divided over all expertises, branches and cultures.
Our coworkers build their own way inside the company, the services and the expertise.
**SGS Life Sciences** carries out all type of **services for pharmaceutical and biotechnology companies**, from coordination and running of clinical trials with new molecules or techniques on human beings, to support and consultancy on post marketing registration activities. **SGS Life Sciences** has also expertise in the quality control of pharmaceuticals.
**The Quality Assurance Department** of SGS Clinical Research is an independent department responsible for the Quality Management System. This covers all quality documents, training and qualification, resolution and documentation of non-conformances, auditing activities and dedicated quality support to all operational teams (i.e. Clinical Pharmacology Unit, Clinical Operations, Biometrics and Medical Safety & Regulatory, and Business Development and Support).
We are currently looking for a **Quality Assurance Auditor**
**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:
- 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.
- 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.
- 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.
- Participate in the yearly vendor evaluation.
- 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?
- 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.
- You have **at least 3 years of clinical research or auditing experience **in an industry setting.
- 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.
- You are fluent in English. Knowledge of Dutch is a plus.
- 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.
- You have a strong affinity with (inter)national guidelines and regulatio
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