Quality Assurance Specialist
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- Drafting and reviewing quality documentation within the scope of the project (project notes, quality plans, etc.)
- Reviewing and approving electronic master batch records in MES Pas-X
- Preparing and reviewing project documentation (e.g., procedures, risk assessments) with a focus on deviation prevention (DPP) and human error prevention (HEP)
- Ensuring compliance with SOPs, global standards, regulations, and product registration (filing) regarding clinical and commercial manufacturing
- Supporting cross-departmental collaborations
- Knowing when to escape issues to the supervisor/manager
Required Skills & Qualifications:
- Master's degree in a scientific discipline or equivalent experience
- Knowledge and interpretation of cGMP in a regulated environment
- Experience with electronic batch records and related digital systems
- Knowledge and experience with quality processes and quality assurance
- Excellent accuracy and attention to detail
- Independence and a strong sense of responsibility
- An enthusiastic team player with strong communication skills
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