Senior Quality Assurance Specialist
Vor 4 Tagen
The role of Senior Quality Assurance Specialist is crucial in ensuring the highest standards of quality are maintained throughout the product lifecycle. As a key member of the global quality team, you will be responsible for leading quality improvement initiatives and providing regulatory oversight on all product quality aspects.
Your Responsibilities:
- Lead cross-functional quality improvement projects to streamline change control handling in regulatory dossiers and release processes.
- Ensure compliance with GMP regulations and pharmaceutical quality standards.
- Provide project management support, including planning, scheduling, and coordination of activities.
- Collaborate with stakeholders to drive process efficiency and ensure successful implementation.
About You:
- Educational Background: University degree (minimum 4 years) in Pharmacology, Biochemistry, Chemistry, Chemical Engineering, or equivalent.
- Industry Expertise: At least 5 years of Quality Assurance experience in commercial pharmaceuticals under GMP.
- Regulatory & Compliance Knowledge: Strong understanding of EU/FDA GMP requirements, regulatory dossiers, and release processes.
- Project Management: Proven track record in pharmaceutical project management, ideally with complex supply chains & CMO/CLO management.
- Communication & Leadership: Excellent stakeholder management skills, with the ability to work collaboratively in a global team environment.
- Language Skills: Fluent in English (spoken & written).
What's in it for You:
- 6-month interim contract in a global biopharmaceutical company.
- Exciting opportunity to lead a high-impact quality improvement project.
- Work in Basel, Switzerland, with a flexible hybrid model (minimum one day on-site required).
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