stillingsbetegnelse: QA Senior Manager, Facility Validation

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! Do you want to manage a team of 9 highly dedicated specialists that are responsible for validation and qualification activities for facility and computerized systems? Do you want to play a key role in bringing numerous pharmaceutical productions safely and efficiently to market? Then join CMC Biologics in a new QA Senior Manager position and become part of an international and modern organization that delivers biopharmaceutical development and manufacturing right and on time. Deliver quality assurance of biopharmaceutical products and API You will be responsible for daily management of the team, which includes, people management, strategic planning of validation activities, prepare and approve documents, and facilitate continual improvement of the systems. We are preparing the Site for an FDA Pre-Approval Inspection (PAI), expected to take place in autumn this year. The Facility Validation Team has key responsibilities during the PAI Inspection. Develop your GMP skills and build relations with highly skilled people from the industry 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 a lot of 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. QA Senior Manager You have 5-10 years experiences with interpretation of global cGMP rules concerning manufacturing and quality assurance of biopharmaceutical products and API. Our Quality System is compliant to ICH Q7 and relevant parts of FDA 21 CFR part 11, 210, 211, 600 and 610. You have a relevant academic background within pharmacy, biotechnology or similar. Ideally you have knowledge in several of the following areas: • Commercial GMP production and/or with production for late stage clinical trials. • Production of biotechnological products and APIs. • People Management. • IQ, OQ, PQ related to facility equipment. • Qualification of clean utilities. • Cleaning Validation (CV). • Validation of computerized systems. • Regulatory inspections e.g. EMA, FDA and customer audits (internal and external audits). 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 business partner Jeppe Højrup, telephone +45 2294 2942. The applications will be processed continuously, so please apply as soon as possible and no later than March 20th, 2015. 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 manufacturing or sophisticated, stand-alone analytical, formulation and stability services. CMC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line developme

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