Formulation Support Professional
16 hours ago
We are a cutting-edge CDMO with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina, and College Station, Texas, USA. Our site in Hillerød brings together expertise, capabilities, and technologies to manufacture advanced biologics for late-phase and commercial use.
Responsibilities- Prepare/Update operational documents (SOPs and WIs)
- Support creation of electronic Master Batch Records (PAS-X)
- Participate and support activities related to initial and ongoing Aseptic Process Simulation (APS)
- Participate in Tech transfer activities and implementation of new programs for our area
- Contribute to Risk assessments related to ongoing manufacturing and new products
- First line supporting role for DP operation including training of colleagues
- Support handling of events and deviations
- Drive or support changes for our area
- Continuous improvements on e.g. flows of personnel, materials and equipment, CMRs and document updates
- Identification and implementation of corrective and preventive actions (CAPAs) to prevent re-occurrence and improve compliance
Your Talent & Experience:
- You have a bachelor's or master's degree within Pharmaceutical Sciences, Process Engineering, or similar degree
- Preferably, you have a minimum of 1-2 years of experience within aseptic manufacturing in the Pharmaceutical/Biotech industry
- You can work independently on compliance-related tasks, events, and optimization projects
- You can manage multiple stakeholders and are motivated by the interface between QA, MSAT, and Manufacturing
- You understand regulatory requirements and can execute within their framework
- You have a high level of technical writing skills and excellent communication skills in English and Danish (spoken and written)
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