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水平: Mid-Senior level
工作类型: Contract
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工作内容
Analytical Outsourcing CoordinatorLocation – Beerse
Duration – 12 months
Hybrid working
FTE (%): ideally 100% required – 80% is possible if it’s a good fit.
Rate 63Euros/hr – 68 Euros/hr
- Act as a Single Point of Contact (SPOC) for our external contract labs along with External Alliance Manager SPOC.
- Ensure GMP compliance with regulatory requirements.
- Support Analytical Development (AD) departments with their relationship and communication with external laboratories (ECLs) and Contract Development Manufacturing Organizations (CDMOs)
- Support clinical release and stability (CRS) with capacity planning at preferred external contract labs.
- Assist with the initiation of Work Orders (WO’s)/Purchase Orders (PO’s) at external contract labs and CDMOs (through the close collaboration with External Alliance
- Manager, AD project managers, and Contract Management teams.
- Assist with the scheduling of weekly/monthly analytical meetings with CDMOs and ECLs to support AD project timelines.
- Support the Stability Project Owners, release planners and AD project managers with project timelines and due date tracking of analytical activities at CDMOs and ECLs
- Connection with other ECL SPOC colleague and External Alliance manager to ensure adequate capacity planning at external ECL sites for AD activities.
- Bachelor’s degree in chemistry, Pharmaceutical Sciences, Bio-engineering or equivalent.
- 5 years’ experience in the biopharmaceutical or pharmaceutical industry.
- Experience with pharmaceutical analytical testing
- Experience in small molecule/synthetic chemistry, analytics, and stability.
- Proven ability to build and maintain customer relationships, shows strong communication skills, internally and externally.
- Ability to foster team productivity and cohesiveness, and to work collaboratively, internally and externally.
- Experience with GMP guidelines, policies, pharmaceutical legislation, and industry practices concerning analytical development in clinical development.
- Knowledge of clinical development processes and phases of development within the pharmaceutical industry.
- Project management and problem-solving skills.
- Background in pharmaceutical QA processes and procedures (i.e., deviation, CAPA, Change Control, Quality Agreements, audits)
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最后期限: 27-12-2025
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