This job is currently Archived,
Posted on : 10 July 2017
- Our company is looking for an experienced analytical scientist to our QC laboratory.
- We are looking for a person with strong professional skills within quality control, GMP, validation, qualification, analytical chemistry and trouble shooting.
- The analytical scientist should co-operate and communicate both internally within the QC department and other departments in our company but also externally in relation to our contract laboratories and our CMOs.
- The main responsibility is support to the laboratory technicians and the rest of the organization, release of starting materials, and approval of analytical results, validation and qualifications.
The QC Laboratory
The QC Laboratory at our company is a part of our quality unit consisting of quality assurance and the QC laboratory.
- The QC laboratory is headed by the QC manager and consist now of 18 employees, including laboratory technicians, analytical scientists and laboratory assistant. The QC laboratory is responsible for all matters as typical carried out by a QC laboratory in the pharmaceutical industry.
- The task involves analytical testing of starting materials, of in-house samples, in process controls as well as testing of APIs and sterile injectable products manufactured by our company.
- The QC laboratory is writing protocols, carrying out stability studies and is writing stability reports.
- Validation and qualification of laboratory equipment and technology transfer of methods to other laboratories is also part of the work in the QC laboratory. Development of new methods for analyses of new product develop within our company is performed in the QC laboratory in collaboration with production and development.
- The QC laboratory is responsible for ensuring that all work, within the laboratory, is performed in accordance to the cGMP and relevant laws and legislation.
- QC approval of products manufactured in our company(both release testing, stability studies and project samples)
- Analytical method development and validation of analytical procedures for new products
- Qualification of laboratory equipment
- Support to the laboratory technicians, the production, development, supply chain and regulatory affairs
- Handling of changes , OOS results and deviations within QC
- Stability studies, write protocols, teste plans and reports
The QC analytical scientist should preferably meet the following professional skills:
- Formal education at M.Sc. degree within a scientific discipline e.g. pharmacist, Cand. Scient, or engineer
- Strong knowledge of the quality processes and analytical methods (HPLC, AAS, GPC, IC and microbiology) a minimum of 4 years of QC experience expected, including laboratory experience
- Enthusiastic about and interested in laboratory work
- Experience with GMP regulations from pharma industry
- Experience with close relationship with production, QA and regulatory affairs
- Ability to handle complex situations and problems
- Language skills: fluent in Danish and English. Ability to write in English
- Analytical and systematic
- A do er getting things done, also when the pressure is high
- Ability to prioritise
- Proactive approach and systematic problem solving
- Communicates effectively at all levels in a clear, fluent and precise manner.
- Team player
- Strong personal skills with a high degree of personal drive - easy going and open minded, service oriented
DK 4300 Holbaek Denmark
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