{"id":14633,"date":"2024-10-02T12:23:39","date_gmt":"2024-10-02T16:23:39","guid":{"rendered":"https:\/\/www.blackdiamondnet.com\/jobs\/eu-hybrid-qa-contractor-french-speaking-235899\/"},"modified":"2024-10-02T13:32:24","modified_gmt":"2024-10-02T17:32:24","slug":"eu-hybrid-qa-contractor-french-speaking-235899","status":"publish","type":"jobs","link":"https:\/\/www.blackdiamondnet.com\/fr\/jobs\/eu-hybrid-qa-contractor-french-speaking-235899\/","title":{"rendered":"EU (Hybrid): QA Contractor (French Speaking) (235899)"},"content":{"rendered":"<p><span style=\"text-decoration: underline;\"><strong>Job Description:<\/strong><\/span><\/p>\n<ul>\n<li>We are seeking a QA Contractor to support our team in conducting data reviews that support source documents \/NDA Module submissions. This role requires prior QA expertise working in a production site for drug substance, preferably with synthetic peptides<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span style=\"text-decoration: underline;\"><strong>Responsibilities:<\/strong><\/span><\/p>\n<ul>\n<li>Conduct review of process development and manufacturing raw data, and other types of data used to generate source documents and NDA Module submissions<\/li>\n<li>Ensure compliance with regulatory standards and internal quality requirements.<\/li>\n<li>Collaborate with cross-functional teams to address process related queries.<\/li>\n<li>Perform electronic virtual data reviews of the CMO generated data<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span style=\"text-decoration: underline;\"><strong>Requirements:<\/strong><\/span><\/p>\n<ul>\n<li>Proven experience in data reviews.<\/li>\n<li>Background in DS manufacturing \/ process development, process validation working in GMP environment<\/li>\n<li>Ability to critically analyze and review technical documents.<\/li>\n<li>Strong communication skills to effectively collaborate with internal and external stakeholders.<\/li>\n<li>Must be able to read\/speak French and English fluently<\/li>\n<li>5+ years of pharma experience in GMP production site for drug substance, manufacturing process focus, preferably with synthetic peptides.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span style=\"text-decoration: underline;\"><strong>Desired Qualifications:<\/strong><\/span><\/p>\n<ul>\n<li>Prior experience in performing review of data for source documents for NDA Module submissions.<\/li>\n<li>Familiar with GMP principles<\/li>\n<li>Highly effective organizational, communication and interpersonal skills<\/li>\n<li>Flexibility to work across different time zones.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>EU (Hybrid): QA Contractor (French Speaking) (235899)<\/p>\n<p>#LI-Hybrid<\/p>\n","protected":false},"excerpt":{"rendered":"<p>EU (Hybrid): QA Contractor (French Speaking) (235899) We are seeking a QA Contractor to support our team in conducting data reviews that support source documents \/NDA Module submissions. This role requires prior QA expertise working in a production site for drug substance, preferably with synthetic peptides<\/p>\n","protected":false},"featured_media":0,"template":"","tags":[],"service_area":[368],"location":[527],"job_status":[585],"class_list":["post-14633","jobs","type-jobs","status-publish","hentry","service_area-sciences-de-la-vie-et-technologie","location-leurope","job_status-closed"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-10-15 13:26:22","action":"category","newStatus":"draft","terms":[585],"taxonomy":"job_status","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/jobs\/14633","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/jobs"}],"about":[{"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/types\/jobs"}],"wp:attachment":[{"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/media?parent=14633"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/tags?post=14633"},{"taxonomy":"service_area","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/service_area?post=14633"},{"taxonomy":"location","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/location?post=14633"},{"taxonomy":"job_status","embeddable":true,"href":"https:\/\/www.blackdiamondnet.com\/fr\/wp-json\/wp\/v2\/job_status?post=14633"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}