Senior/Principal Scientist, Quality Control
2 months ago
Join a dynamic and international company where everyone is responsible for delivering right on time as one team
The Position
By joining the QC Raw Material team, you will be key in implementing new raw materials to support new phase I/II projects as well as planning the Raw Material Qualification and Release Testing program for late stage projects. As part of daily release flow, you will be responsible for test planning of incoming raw materials, keeping Raw material specifications in compliance, assessing Supplier Change Notifications, as well as providing scientific solutions to contract labs.
Key responsibilities
- Author and review raw material specification based on European or US regulatory guidelines as well as adapting to supplier change notifications
- Deliverance of scientifically sound and cGMP compliant raw material documents and analytical results.
- Involvement in operating the raw material program, including risk assessments and creating qualification protocol/reports
- Oversight of sampling, as well internal as outsourced testing.
The Profile
The ideal candidate holds an MSc or PhD degree in Chemistry, Pharmaceutical Sciences or other relevant area and preferably with work experience within quality control or quality assurance. In addition, we expect you to bring some of the following experience and characteristics:
- Profound writing and reviewing skills of cGMP documents: raw material specifications, test methods, general procedures
- Experience setting specifications for compendial and non-compendial raw materials
- In depth understanding of US and European pharmacopoeias
- Experience handling change controls, deviations and CAPAs including root cause investigation, and Laboratory Investigations
- You are an experienced multi-tasker and you enjoy working in a high pace and being challenged in a busy business
- You are a team player combined with the ability and desire to work independently
- Experience with contract manufacturing and business understanding
- Experience in representing area in Audits and Inspections
Location: Copenhagen Site
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