(senior) Clinical Quality Assurance Auditor ()

Beschrijving:

The primary responsibility of the Clinical Quality Assurance Auditor is to conduct audits, independent from operational functions, to assure trial related activities were conducted, and the data were generated, recorded, analyzed and accurately reported according to the protocol, Standard Operating Procedures, GCP, and applicable regulatory requirements. The key elements of the job description are: 1 – Auditing • Perform GCP internal and external audits as lead auditor or co-auditor. This includes: o Systems audits o Clinical Trial audits o Subcontractor/supplier audits (routine, for cause and due diligence assessment) o Computerized systems validation audits • Perform all audit related activities including planning, conduct, and timely reporting of audit findings (independently) according to SGS LSS procedures or sponsor’s procedures (contracted audits), if applicable. • Monitor, in close collaboration with the operational departments, that CAPAs are implemented appropriately and within proposed timelines. • Facilitate sponsor audits and regulatory inspections at SGS LSS according to internal procedures. • Provide leadership and training to audit teams for complex systems audits. 2- SOPs • Serve as author of QA SOPs, as assigned. • Review SOPs for clarity, internal consistency, and consistency with other related SOPs. • Serve as QA representative on Global SOP Taskforce(s) for the development and revision of general or functional SOPs, as assigned. 3 – GCP Consultancy • Provide interpretation and consultation to project teams on (new/updated) regulations, guidelines, compliance status and policies and procedures. • Advise on best approaches to remediate and resolve issues brought to QA attention. – University degree of at least two cycles in (para-) medical, pharmaceutical or sciences. Equally recognized degree and/or relevant qualifications by experience may also be acceptable and will be evaluated on a case-by case basis. – Minimum of 6 years of clinical research experience in a pharmaceutical company or CRO or equivalent combination of education, training and experience – Minimum of 4 years auditing experience of which a minimum of 2 years in GCP or equivalent combination of education, training and experience. A fascinating job within a scientific world ! SGS is the world’s leading inspection, verification, testing and certification company. The company employs over 75 000 people and operates a network of more than 1 000 offices and laboratories around the world. In Belgium 1.650 people are working for SGS. One of the business segments, SGS Life Science Services, is a leading contract research organization (CRO) offering Clinical Research and Quality Control/Laboratory Testing Services to the pharmaceutical and biopharmaceutical industry. It provides outsourcing services on both the quality and safety of drug ingredients and the drug development process – from the early development stages until the commercialization of the finished product. We are looking for a: (senior) Quality Assurance Auditor (Mechelen) Please apply online via: www.be.sgs.com/Careers. Should you have further questions, please contact us on [email protected]

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