{"id":13984,"date":"2024-06-20T08:42:49","date_gmt":"2024-06-20T12:42:49","guid":{"rendered":"https:\/\/www.blackdiamondnet.com\/jobs\/south-of-paris-fr-qa-contractor-235194\/"},"modified":"2024-06-20T08:42:49","modified_gmt":"2024-06-20T12:42:49","slug":"south-of-paris-fr-qa-contractor-235194","status":"publish","type":"jobs","link":"https:\/\/www.blackdiamondnet.com\/de\/jobs\/south-of-paris-fr-qa-contractor-235194\/","title":{"rendered":"South of Paris, FR: QA Contractor (235194)"},"content":{"rendered":"<p><span style=\"text-decoration: underline;\"><strong>Duration:<\/strong><\/span><\/p>\n<ul>\n<li>Till end of the year, option to extend at year end<\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline;\"><strong>Onsite:<\/strong><\/span><\/p>\n<ul>\n<li>3 days first week onsite, then hybrid and open to mostly remote<\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline;\"><strong>Job description:<\/strong><\/span><\/p>\n<ul>\n<li>Our client has a need for a GCP\/QA Contractor to join the team at their facility just south of Paris. The ideal candidate would have 5+ years of experience and 1+ years of GCP or CQA experience. They would be responsible for assisting with clinical trials, handling basic GCP activities, managing documentation, and a plus would be background or understanding of regulatory authority inspection.<\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline;\"><strong>Purpose of the role:<\/strong><\/span><\/p>\n<ul>\n<li>Act as the primary clinical quality contact for entities or individuals involved in clinical trials conduct<\/li>\n<li>Support and oversee the quality event\/ Serious breach management<\/li>\n<li>Support and oversee the CAPA management activities<\/li>\n<li>Support the inspection readiness activities<\/li>\n<li>Support audits activities<\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline;\"><strong>Duties and Responsibilities:<\/strong><\/span><\/p>\n<p><strong>Clinical study QA representative <\/strong><\/p>\n<ul>\n<li>For the clinical studies assigned, works with the study team to ensure good clinical practices and compliance to the relevant regulatory requirements are met<\/li>\n<li>Participate to project meeting and ensure timely assistance for all quality related topics<\/li>\n<li>Participate to service provider selection and quality oversight for the studies assigned<\/li>\n<li>Escalate to QA TA Lead identified issues that require further support and assistance<\/li>\n<\/ul>\n<p><strong>QMS Process<\/strong><\/p>\n<ul>\n<li>Quality Event and Serious Breach<\/li>\n<li>Review and approve major\/critical Quality Events and potential Serious Breaches<\/li>\n<li>Corrective and Preventive Actions (CAPA):<\/li>\n<li>Support business functions, and tracking to timely completion, of Corrective and<\/li>\n<li>Preventive Actions, contributing to root cause and risk analysis of clinical research matters, and assisting in establishing the effectiveness of implemented CAPA.<\/li>\n<li>Report CAPA status and metrics, escalating any issues regarding delayed timelines or ineffectiveness of CAPA, as needed<\/li>\n<li>Ensure timely delivery by following up with CAPA owners and scheduling meetings as necessary<br \/>\nand facilitating Quality Risk Management activities<\/li>\n<li>Quality Documents<\/li>\n<li>Contribute to the continuous improvement of R&amp;D Quality Documents as assigned<\/li>\n<li>Quality Assessments<\/li>\n<li>Contribute to the Quality Assessments\/Self-Inspection as assigned<\/li>\n<\/ul>\n<p><strong>Audits and inspections<\/strong><\/p>\n<ul>\n<li>Support inspection readiness activities for high-risk studies:<\/li>\n<li>Support sponsor mock inspection, quality assessment activities,<\/li>\n<li>Conduct the quality control of study documents<\/li>\n<li>Set up regular meetings with Subject Matter Experts (SMEs) (including Service Provider), workstreams per topics to enable successful preparation outputs\/deliverables,<\/li>\n<li>Monitor progress of the preparation of the inspection and report the risks identified, any remediation actions,<\/li>\n<li>Assist in the preparation and conduct of inspection as required.<\/li>\n<li>Ensure timely data entry within the eQMS<\/li>\n<li>Support the audit activities: provide information to audit group for their risk assessment and audit activities, facilitate further investigation of observations (when needed), root cause analysis and definition of CAPA.<\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline;\"><strong>Ausbildung<\/strong><\/span><\/p>\n<ul>\n<li>Contribute to training sessions as SME, by reviewing training materials or participating in presentations where needed.<\/li>\n<li>Guide system users to ensure they are trained when required (e.g. when a specific training task is required in eLMS)<\/li>\n<li>Liaise with process owners and trainers to ensure appropriate training material is generated and made available for clinical research activities.<\/li>\n<\/ul>\n<p><span style=\"text-decoration: underline;\"><strong>Experience &amp; Qualifications:<\/strong><\/span><\/p>\n<ul>\n<li>Minimum 5 years\u2019 experience in Quality Assurance in the pharmaceutical industry in management of quality system<br \/>\nincluding experience at corporate level preferably in Research and Development<\/li>\n<li>Language : English<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>South of Paris, FR: QA Contractor (235194)<\/p>\n<p>#LI-Hybrid<\/p>\n","protected":false},"excerpt":{"rendered":"<p>South of Paris, FR: QA Contractor (235194) Our client has a need for a GCP\/QA Contractor to join the team at their facility just south of Paris. The ideal candidate would have 5+ years of experience and 1+ years of GCP or CQA experience.<\/p>\n","protected":false},"featured_media":0,"template":"","tags":[],"service_area":[395],"location":[544],"job_status":[595],"class_list":["post-13984","jobs","type-jobs","status-publish","hentry","service_area-biowissenschaften-und-technologie","location-europa","job_status-closed-de"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-07-28 08:36:59","action":"category","newStatus":"draft","terms":[585],"taxonomy":"job_status","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.blackdiamondnet.com\/de\/wp-json\/wp\/v2\/jobs\/13984","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.blackdiamondnet.com\/de\/wp-json\/wp\/v2\/jobs"}],"about":[{"href":"https:\/\/www.blackdiamondnet.com\/de\/wp-json\/wp\/v2\/types\/jobs"}],"wp:attachment":[{"href":"https:\/\/www.blackdiamondnet.com\/de\/wp-json\/wp\/v2\/media?parent=13984"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/de\/wp-json\/wp\/v2\/tags?post=13984"},{"taxonomy":"service_area","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/de\/wp-json\/wp\/v2\/service_area?post=13984"},{"taxonomy":"location","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/de\/wp-json\/wp\/v2\/location?post=13984"},{"taxonomy":"job_status","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/de\/wp-json\/wp\/v2\/job_status?post=13984"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}