stillingsbetegnelse:
QA Principal Scientist for Cleaning and 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 be part of a team of 9 highly dedicated specialists that are responsible for validation and qualification activities for facility and computerized systems? Are you among the best in class in terms of skills for process cleaning validation and qualification of equipment? Do you want to play a key role in bringing numerous pharmaceutical productions safely and efficiently to market? Then join CMC Biologics in a QA specialist 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, in collaboration with our specialists, be responsible for the overall strategy for process cleaning verification and validation in our multipurpose manufacturing plant. Our project covers early development of API to clinical phase 1-2-3 batch production to final process validation (PPQ) and commercial manufacturing. You will be part of a team of specialist from QA, process development, production, analytical development and QC. You will participate in strategic planning of validation activities, prepare SOPs, protocols and reports, and in general 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 a key role during the FDA 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 at CMC Biologics in CPH and with colleagues from our sister sites in Seattle and Berkley USA 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 Professional (Principal Scientist) for Cleaning and Facility Validation You have 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 documented skills in several of the following areas: • Production of biotechnological products and APIs from development to late stage clinical production and validation of process (PPQ). • Cleaning verification and validation during process development, including scientific evaluation of pharmacological and toxicological data to support threshold values for safety (NOEL and Permitted Daily Exposure, PDE). • Risk assessment tools. • IQ, OQ, PQ for facility equipment. • Qualification of clean utilities. • 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 Jep

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