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- ...tæt kontakt med patienterne. • Kan bevare overblik, prioritere opgaver og samarbejde konstruktivt – også når tempoet er højt. Om Capio Capio Privathospital Odense er et dagkirurgisk hospital, hvor patienten altid er i centrum. Vi arbejder på tværs af faggrupper og...
- ...proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c) If you need an accommodation filling out an application or applying to a job please email...
- ...surpass their goals and reach an overall high level of performance (raising the bar) Protect/breath the team- and company culture (cfr. the way we do things) Leading by example by closing deals and managing your own sales cycles Facilitate/support group sales initiatives...
- ...action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c) If you need an accommodation filling out an application or applying to a job please email Required Experience:...
- ...experience in quality assurance in a regulated industry – preferable within medical device Experience working with ISO 13485, FDA 21 CFR Part 820 and other relevant standards and regulations Experience with design control of software and hardware devices...
- ...maintenance and compliance of ALKs Quality System and cultivate a culture of quality in alignment with e.g. ICH Q9/Q10 EU GMP and FDA 21 CFR Parts 210/211 MDR. Actively participate in designing implementing training and continuously improving ALKs quality processes and...
- ...guidelines as well as international regulations pertaining to the production of biopharmaceutical products (including but not limited to 21 CFR Partsand 610; EU GMP Parts I II and III and relevant ICH guidelines). Ability to be pragmatic and still ensure compliance....
- ...proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c) If you need an accommodation filling out an application or applying to a job please email...
- ...inspection techniques Experience working with suppliers Knowledge of medical device regulations and standards, ISO 13485, FDA 21 CFR 820, (med-tech) Understanding of product and/or supplier validation processes (preferred) Proficiency in MS Office Bachelor’s...
- ...objective of the team is to ensure that our production facilities and laboratories comply with current GMP standards including EU GMP 21 CFR and ICH guidelines at all times. The team is mainly responsible for the review and approval of quality documentation including...
- ...quality management systems documentation practices and audit readiness. Understand frameworks like GxP (GAMP5 ed.2 Annex 11 FDA 21 CFR Part 11 etc.) ISO27001 and data integrity principles. Can translate complex regulatory requirements into practical actions. Are...
- ...Have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g. ICH Q7A 21 CFR Part 211 etc.). Have experience writing reviewing and approving GMP documentation. Experience with operations of single-use...
- ...Experienced within injection devices (ISO11608-1&2:2022) design control and drug-device combination product legislation (ISO13485 MDR 21 CFR Part 820 and 4). Experience with change control deviation and CAPA management control setup and product quality complaints....
- ...understanding- and interpreting legislation to ensure manufacturing is in compliance with current standards for GMP production i.e. EU GMP 21 CFR and ICH guidelines. Continuously we improve our standards within quality- and manufacturing processes innovate with modern technology...
- ...se dig selv i en rolle, hvor din struktur, dit drive og din evne til at samarbejde på tværs af organisationen er afgørende for, at Capio lykkes som Danmarks foretrukne sundhedsudbyder? Så kan du meget vel være vores nye Bid Manager! Vækstrejsen hos Capio I Capio sætter...
- ...kvalitet, patientkontakt og tværfagligt samarbejde – uden at give køb på din work-life balance? Så er det måske dig, vi leder efter. Hos Capio Aarhus søger vi en engageret og erfaren operationssygeplejerske. gerne med erfaring indenfor knæ- og hofte alloplastik. Vi har...
- ...understøtter både drift, medarbejdere og patientforløb? Så er det måske dig, vi leder efter som vores nye ledende sygeplejerske på Capio Privathospital i Odense. Vi søger en handlekraftig og fagligt stærk leder, der kan stå i spidsen for vores senge-, operations-,...
- ...moderne og nyrenoverede omgivelser, sammen med dygtige kollegaer? Så har vi muligheden til dig. Vores ambition for patienterne Hos Capio stræber vi efter at levere patientoplevelser af høj faglig kvalitet. Vi søger derfor en speciallæge i gynækologi med minimum 2 års...
- ...fokus? Så er det måske dig, vi søger. Vi søger en radiograf med tilknytning til mammografi til vores billeddiagnostiske afdeling på Capio Privathospital i Hellerup. Hos os får du en vigtig rolle i et velfungerende team, hvor der er kort vej til beslutninger og stor...
- ...global IT systems supporting pharmaceutical operations comply with internal quality standards and regulatory requirements (e.g., FDA 21 CFR Part 11, EU GMP Annex 11, GxP) Develop and maintain global quality standards for regulated IT systems Collaborate with IT teams...
- ...systems, in a GMP regulated environment. ~ Good knowledge of automation standards such as EU Annex 11, GAMP5, ISA88, ASTM E2500, and 21 CFR Part 11 etc. ~ It’s a requirement that the candidate knows about any other DCS, PLCs and SCADA. ~ It would be considered an...
- ..., and product development teams to ensure compliance with relevant medical device standards (e.g., ISO 13485, IEC 62304, MDR, FDA 21 CFR Part 820). Oversee software development lifecycle, including requirements definition, design, verification/validation, and post-...
- ...søger en afdelingslæge til et barselsvikariat fra den 1. maj 2026. Hvem er vi? Vi er en del af Center for Rusmiddelbehandling (CFR), som består af i alt seks behandlingsenheder, der tilbyder helhedsorienteret behandling. På årsbasis har vi i CFR mere end 4000 borgere...
- ...Responsibilities Compliance Support: Ensure all labelling materials comply with applicable international regulations (e.g., IVDR, FDA 21 CFR Part 809, CLIA and ISO standards). Collaborate with regulatory affairs to interpret and implement labelling requirements....
- ...pharmaceutical, biotechnology, or medical device industry. Knowledge of industry regulations and standards, such as GxP, FDA 21 CFR Part 11, ISO 17025. Experience integrating LIMS systems with other IT systems (ERP, MES, etc.). Competencies and Skills:...
- ...documentation (VMP, URS, risk assessment, test plans, traceability, reports). Understand key frameworks such as EU GMP Annex 11/15, 21 CFR Part 11, GAMP 5; experience with ISMS / ISO 27001 is a given. Have led projects, workstreams or teams and are comfortable in...
- ...både ansatte, borgere, virksomheder og naturen kan trives og blomstre. Vi har ambitioner for byen – og for dig. Kom og vær med! 15-03-2026 Afdeling: CFR Psykiatriens Hus Ansøgningsfrist: 15 March 2026 Placering: Evald Krogs Gade 13A, 8000, Aarhus C, Denmark...