stillingsbetegnelse: Two QA professionals to Quality Assurance

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! We are looking for two new skilled QA Professionals to support increasing QA activities in our QA Department. Key responsibilities for: QA Professional Supplier Qualification: • Perform supplier audits and keep our suppliers in a state of control • Write up and maintain Quality Agreements for our suppliers • Organize and facilitate internal audits for the SIX SYSTEMS • Support during authority inspections from EMA, US FDA and other international authority • Support during customer audits and visits Skills needed: • Lead auditor • +3 years’ experience from the Biopharmaceutical industry • Relevant academic background within pharmacy, biotechnology or similar • Expect 20 – 30 travelling days per year Key responsibilities for: QA Professional Raw Materials & Quality Systems: • QA Subject Matter Expert on approval and release of raw materials • Support and organize activities around document control, staff training and registration of deviations, CAPA and CR in Master Control (EDMS) • Subject Matter Expert on key QMS SOPs, i.e. prepare and approve documents • Collect and maintain data for different quality metrics that monitor quality oversight • Facilitate quarterly Quality Management Review meetings • Facilitate that the Site is kept in a state-of-control • Support the team around our GMP archive Skills needed: • +3 years’ experience from the Biopharmaceutical industry • Experiences with interpretation of global cGMP rules concerning manufacturing and quality assurance of biopharmaceutical products and API • Relevant academic background within pharmacy, biotechnology or similar Deliver quality assurance of biopharmaceutical products and API As QA professional you will play a key role in bringing numerous pharmaceutical productions safely, efficiently and compliant to market. You will become part of an international and modern organization that delivers biopharmaceutical development and manufacturing right and on time. You will cooperate closely with the other teams in QA and departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP. Through internal and external audits, you are exposed to different ways of working with GMP and pharmaceutical manufacturing, and you can expect to build great expertise within these areas by interacting with our many different international customers. Our Quality System is compliant to ICH Q7 and US FDA 21 CFR part 11, 210, 211, 600 and 610. Join an international and agile organization At CMC, you will get great opportunities to work with a varied array of tasks and challenges. You will get experience with our various departments as well as exciting and challenging assignments, Furthermore, you will to a large extend be able to plan your daily work yourself. CMC offers an informal working environment, where high energy and enthusiasm is part of the daily work life. We respect each other and our individual differences. CMC’s employees have a flexible attitude and we help each other to reach deadlines together as one Team. For further information regarding the position, please do not hesitate to contact Vice President for Quality, Bent Hygum, telephone +45 2948 8445 or HR Director Vibeke Didriksen, telephone +45 2948 8410 The applications will be processed continuously, so please apply as soon as possible and no later than June 30, 2016. About CMC Biologics A/S CMC Biologics (CMC) is a global Contract Manufacturing Organization (CMO) with three biomanufacturing facilities in Europe and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturi

Arbejdsgiver Navn: CMC BIOLOGICS A/S

Arbejdsgiver telefonnummer: 70209470

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark