{"id":144,"date":"2018-11-12T16:00:52","date_gmt":"2018-11-12T15:00:52","guid":{"rendered":"http:\/\/vippharma.dk\/about\/"},"modified":"2019-06-12T13:52:26","modified_gmt":"2019-06-12T12:52:26","slug":"om","status":"publish","type":"page","link":"https:\/\/vippharma.dk\/da\/om\/","title":{"rendered":"Om VIPpharma"},"content":{"rendered":"[vc_row][vc_column][vc_column_text]\n<h1>Om VIPpharma<\/h1>\n<p>VIPpharma har siden etableringen i 2009 udf\u00f8rt en lang r\u00e6kke forskelligartede opgaver indenfor kvalitetsomr\u00e5det i pharma branchen, b\u00e5de indenfor CMC og for kommercielle l\u00e6gemidler. Opgaverne har omfattet\u00a0projektledelse, interim ledelse, sparring med ledelsen omkring strategi og implementering, samt specialistopgaver indenfor GXP, f.eks. som en ekstra ressource i en afdeling.<\/p>\n<p>De fleste opgaver str\u00e6kker sig over en l\u00e6ngere periode, fra nogle m\u00e5neder og op til flere \u00e5r, men der l\u00f8ses ogs\u00e5 mindre opgaver, f.eks. af f\u00e5 dages varighed.<\/p>\n<p>Kontakt VIPpharma for et uforpligtende m\u00f8de vedr. netop jeres opgave.<br \/>\nHerunder ses eksempler p\u00e5 opgaver som VIPpharma tidligere har l\u00f8st:<\/p>\n<p>Opgradering af kvalitetssystemer, herunder udarbejdelse og implementering af SOP\u2019er<\/p>\n<p>Projektledelse<\/p>\n<p>Overf\u00f8rsel af aktiviteter (Tech. Transfer), b\u00e5de internt i organisationen, imellem sites og til eksterne partnere<\/p>\n<p>Aktiviteter ved nedlukning af afdelinger eller sites<\/p>\n<p>Interim ledelse<\/p>\n<p>Tr\u00e6ning af medarbejdere<\/p>\n<p>Kontaktperson for opgaver udf\u00f8rt af CMO\u2019er (f.eks. ekstern laboratorium, arkiv og lager)<\/p>\n<p>Aktiviteter i QA<\/p>\n<ul>\n<li>H\u00e5ndtering af \u00e6ndringssager, afvigelser, CAPAs, etc.<\/li>\n<li>Review af dokumentation for analysevalidering, metodeoverf\u00f8rsel, stabilitetsstudier, udstyrskvalificering, etc.<\/li>\n<li>System for product binders indeholdende information omkring APIer, fremstilling, pakning, analyse metoder, etc.<\/li>\n<li>Batch review\/QP release<\/li>\n<li>Systemer for h\u00e5ndtering af reference- og retention samples<\/li>\n<li>Record Retention Management\/Systemer for arkivering af r\u00e5data<\/li>\n<li>Interne audits, leverand\u00f8r audits samt forberedelse til myndighedsinspektioner<\/li>\n<\/ul>\n<p>Aktiviteter i Analytical Development og QC<\/p>\n<ul>\n<li>GMP support, herunder planl\u00e6gning, opf\u00f8lgning og afrapportering p\u00e5 KPI\u2019er<\/li>\n<li>Udarbejdelse af produkt specifikationer og tilh\u00f8rende Justifications til myndighederne<\/li>\n<li>H\u00e5ndtering af stabilitetsstudier, herunder udarbejdelse af dokumentation, trending af data og fasts\u00e6ttelse af udl\u00f8b<\/li>\n<li>System for h\u00e5ndtering af sekund\u00e6re reference standarder, herunder produktion og frigivelse<\/li>\n<li>Systemer for h\u00e5ndtering og fremstilling af kemikalier og reagenser<\/li>\n<li>Opgradering af Validerings master plan (VMP), samt udf\u00f8relse af periodisk review af analysemetoder og -udstyr<\/li>\n<li>Validering af Excel regneark<\/li>\n<\/ul>\n<p>Mentoring &#8211; se mere vedr. mentorforl\u00f8b <a href=\"http:\/\/vippharma.dk\/da\/mentoring\/\">her<\/a>.[\/vc_column_text][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text] Om VIPpharma VIPpharma har siden etableringen i 2009 udf\u00f8rt en lang r\u00e6kke forskelligartede opgaver indenfor kvalitetsomr\u00e5det i pharma branchen, b\u00e5de indenfor CMC og for kommercielle l\u00e6gemidler. Opgaverne har omfattet\u00a0projektledelse, interim ledelse, sparring med ledelsen omkring strategi og implementering, samt specialistopgaver indenfor GXP, f.eks. som en ekstra ressource i en afdeling. De fleste opgaver str\u00e6kker&hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Om VIPpharma - VIPPHARMA<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/vippharma.dk\/da\/om\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Om VIPpharma - VIPPHARMA\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_column_text] Om VIPpharma VIPpharma har siden etableringen i 2009 udf\u00f8rt en lang r\u00e6kke forskelligartede opgaver indenfor kvalitetsomr\u00e5det i pharma branchen, b\u00e5de indenfor CMC og for kommercielle l\u00e6gemidler. Opgaverne har omfattet\u00a0projektledelse, interim ledelse, sparring med ledelsen omkring strategi og implementering, samt specialistopgaver indenfor GXP, f.eks. som en ekstra ressource i en afdeling. 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De fleste opgaver str\u00e6kker&hellip;","og_url":"https:\/\/vippharma.dk\/da\/om\/","og_site_name":"VIPPHARMA","article_modified_time":"2019-06-12T12:52:26+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/vippharma.dk\/da\/om\/","url":"https:\/\/vippharma.dk\/da\/om\/","name":"Om VIPpharma - VIPPHARMA","isPartOf":{"@id":"https:\/\/vippharma.dk\/#website"},"datePublished":"2018-11-12T15:00:52+00:00","dateModified":"2019-06-12T12:52:26+00:00","breadcrumb":{"@id":"https:\/\/vippharma.dk\/da\/om\/#breadcrumb"},"inLanguage":"da-DK","potentialAction":[{"@type":"ReadAction","target":["https:\/\/vippharma.dk\/da\/om\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/vippharma.dk\/da\/om\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/vippharma.dk\/da\/"},{"@type":"ListItem","position":2,"name":"Om VIPpharma"}]},{"@type":"WebSite","@id":"https:\/\/vippharma.dk\/#website","url":"https:\/\/vippharma.dk\/","name":"VIPPHARMA","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/vippharma.dk\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"da-DK"}]}},"_links":{"self":[{"href":"https:\/\/vippharma.dk\/da\/wp-json\/wp\/v2\/pages\/144"}],"collection":[{"href":"https:\/\/vippharma.dk\/da\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/vippharma.dk\/da\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/vippharma.dk\/da\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/vippharma.dk\/da\/wp-json\/wp\/v2\/comments?post=144"}],"version-history":[{"count":20,"href":"https:\/\/vippharma.dk\/da\/wp-json\/wp\/v2\/pages\/144\/revisions"}],"predecessor-version":[{"id":240,"href":"https:\/\/vippharma.dk\/da\/wp-json\/wp\/v2\/pages\/144\/revisions\/240"}],"wp:attachment":[{"href":"https:\/\/vippharma.dk\/da\/wp-json\/wp\/v2\/media?parent=144"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}