What will your job be
As a Separations & Chemistry you will support analytical activities serving as an expert on Separations and Chemical & Physical techniques. Additionally, you will handle quality and compliance related topics (deviations, CAPA, NPI GAP assessments and Change Controls) and you will contribute to maintaining cGMP compliance and support the LEAN status of the team. Your key responsibilities
- Ensuring that the assays can be technically excuted in a manner that is efficicient, cGMP compliant and safe.
- You specifically focus on Separations and Chemical & Physical techniques used for in process control and both product release and stability studies.
- This could be accomplished by means of GAP analysis, protocols and reports performed during the new product implementation (NPI).
- Responsible for creating URS’s in collaboration with automation specialist and provides lab input for the new equipment or technologies to NPI Lead
- You will act as Subject Matter Expert (SME) during cGMP inspections and you are the NPI contact person during technical transfers
- Act as lead investigator for local/global Non-Conformances (conduct the investigation, provide product impact assessments, identify and define appropriate corrective/preventive actions)
- This also include proper lab investigation and CRA’s for the medium/high-level Quality issues
What are we looking for
For the position as a Separations & Chemistry Specialist we are looking for a motivated candidate with expertise on Separations and Chemical & Physical technologies.
- HBO or MSc degree in a relevent discipline (Analytical chemistry, pharmacy, biotechnology or equivalent)
- Multiple years of experience in a cGMP environment (QC/QA/manufacturing).
- Strong experience and knowledge of Separations and Chemical & Physical techniques for the analysis of biopharmaceutical products
- Experience with (c)GMP compliance
- Deviation management experience (non-conformances, corretive/preventice actions)
- Fluent English and Dutch required
What do we offer
- Long term position, which starts with a 12 months contract at CheckMark
- Salary indication from €3000,- gross per month based on a full-time position
- Full-time position
Where will you work
An international pharmaceuticial company involved in the manufacturing of biopharmaceutical products. The team you will work in is responsible for the execution of all analytical test methods using, amongst others, various Separations and Chemical & Physical techniques. Analytical data will support in process control and both product release and stability studies.