Regulatory Compliance Professional
3 days ago
About the Role
This position involves supporting CMC API Development within the raw material and CMO shipping area, ensuring compliance with regulatory requirements, quality standards, and company policies.
You will be responsible for delivering best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and drug product production for clinical trials, as well as participating in regulatory inspections and audits, ensuring compliance with cGMP and other regulatory requirements.
Responsibilities:
- Deliver high-quality assurance of raw materials and CMO shipping area to our drug substance and drug product production for clinical trials.
- Challenge and approve documents in connection with raw materials and CMO shipping.
- Ensure compliance with cGMP and other regulatory requirements during regulatory inspections and audits.
- Secure quality agreements with external suppliers.
Requirements:
- MSc in Pharmaceutical Sciences, Engineering, Biochemistry, or similar.
- At least 1 year of experience from the pharmaceutical industry within quality or production.
- Experience with GMP.
- Experience working with raw materials for API production.
- Proficiency in English.
The successful candidate will have a strong understanding of quality principles and be able to apply this knowledge in a practical setting.
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