QA Scientist for Facility Validation
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? 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 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 validation and be our regulatory expert within validation and qualification requirements.
You will be part of a team of specialist from QA, Validation, 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.
You will also write up annual performance reports for the systems and facilitate continual improvement of the systems.
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.
Academic QA with pharmaceutical validation experience
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 QA knowledge in several of the following areas:
• Production of biotechnological products and APIs from development to late stage clinical production and validation of process (PPQ).
• Statistical evaluation and continuous process verification.
• IQ, OQ, PQ related to facility equipment
• Qualification of clean utilities
• Cleaning Validation
• 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. It is essential that you can combine a theoretic background with a practical approach to validation.
For further information regarding the position, please do not hesitate to contact HR business partner Jeppe Højrup, telephone +45 2294 2942 or Director of Quality Lise Marie Christensen, telephone +45 29943058
To apply, please use the link below. The applications will be processed continuously, so please apply as soon as possible and no later than November 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 development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics’ innovative approach to cell line and process development.
Visit <a href='javascript:openLinkWindow("http://www.cmcbiologics.com")' "="" data-cke-saved-href='javascript:openLinkWindow("http://www.cmcbiologics.com")'>www.cmcbiologics.com to learn why CMC Biologics is a World Leader in process development and contract manufacturing.
