stillingsbetegnelse:
Quality Assurance Scientist / Qualified Person for QA Operations

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! QA Operations Team QA Operations consists of highly qualified technicians and scientists with various professional backgrounds and several years of experience within Quality Assurance. Besides the Operations team, the quality unit department consist of the teams Quality Systems, QA Facility and QC. The main responsibility of the Operations team is quality assurance of manufacturing activities, batch release and QC documentation. We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim at constantly ensuring that manufacturing and QC activities are in compliance with current standards for GMP production, i.e. 21 CFR, ICH guidelines and EU GMP. The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high service level to our colleagues in the rest of CMC - and not least to our international customers. The Operations team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration. Tasks and Responsibilities As QA Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment. The team handles review and approval of quality documentation e.g. QC documentation, Batch Production Records, Master Production Records, specifications, analytical procedures, stability documentation, validation processes (manufacturing process and analytical method validations), change requests, deviations and CAPAs. You will contribute to the handling of mentioned team tasks, but your main focus will be on activities related with batch release and preparation here off. Also you will be handling quality related activities for specific customer projects and participate in external as well as internal audits. We cooperate closely with the other departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP. Your Profile Preferably you have +5 years of experience with quality assurance of API manufacturing and release of DS / DP. It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, biology or similar. Ideally you have experience with a number of the following areas: • Requirements for commercial and/or late state clinical phase GMP manufacturing of biological intermediates, APIs and Cell Banks. • Review and evaluation of Master and Batch Production Records. • Quality assurance of manufacturing process validation. • QC, analytical methods, validation and stability documentation.. • QP Certification of API, cell banks or FP batches for EU and US markets. • Professional presentation of quality in customer relations. • QA oversight of manufacturing activities. It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience. CMC has international customers and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent. CMC offers CMC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. CMC offers an informal working environment, where humor is part of the daily work life. We respect each other and our in

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