Description
My client is currently working on a huge FDA project near Copenhagen and looking for freelancers with experience in the QC raw material process and methods validation and also professionals that have expertise in the QC Equipment Qualification.The Frame:
- Start: ASAP
- Days per week: 4-5 days
- Contract length: till the end of the year
- Location Copenhagen, Denmark
My client is currently working on a huge FDA project near Copenhagen and looking for freelancers with experience in the QC raw material process and methods validation and also professionals that have expertise in the QC Equipment Qualification.
Job Description:
QC Materials Expert:
- Create an overview of materials used in QC methods, in corporation with internal stakeholders
- Describe and validate production and sourcing processes for QC materials.
- Implement and update QC materials in manufacturing systems
- Plan, execute and prioritize the responsibilities and tasks according to agreed objectives together with project manager and rest of the team.
QC Equipment Expert:
- Experience qualifying and validation equipment from the laboratory, production plant and utilities such as Protein purification, chromatography systems, mixing, dialysis, shaking, filling lines, buffer tanks, filtration systems , concentration cells, gas compression systems
- Strong documentation skills in writing and reviewing reports / protocols..
Experience:
- Education: MSc in Biology, Natural Science, Pharmacy, Vet or similar.
- + 5 years of relevant experience.
- Experience with immunological techniques and preferably molecular biology.
- Experience from R&D, process development or production support in a Life Science experience
- Knowledge of GMP regulated areas
- Experience with documentation and validation.
- High drive and focused on creating results.
- Analytical and systematic work approach.
- Can take part in goals and direction setting.
- Good communication skills and good at working with others in cross functional groups in a busy working environment.
- Fluently in English.
- Fluently in Danish is desirable.
The Frame:
- Start: ASAP
- Days per week: 4-5 days
- Contract length: till the end of the year
- Location Copenhagen, Denmark