
Product Quality Expert
vor 1 Tag
Global Quality Team Member:
We are looking for a skilled Product Quality Lead to join our Global Quality team. As a key contributor, you will lead a quality improvement project to optimize change control handling in regulatory dossiers and release processes. Your expertise will ensure compliance with GMP regulations and pharmaceutical quality standards for commercialized pharmaceuticals.
Key Responsibilities:
- Develop and implement quality improvement initiatives to drive process efficiency and ensure successful implementation.
- Manage product quality oversight for 1-3 medicinal products, ensuring compliance throughout their lifecycle.
- Collaborate with cross-functional teams involved in product lifecycle management to ensure seamless execution.
- Provide assessment, guidance, and regulatory oversight on all product quality aspects.
- Ensure audit and inspection readiness in collaboration with internal teams.
Required Skills:
- University degree (minimum 4 years) in Pharmacology, Biochemistry, Chemistry, Chemical Engineering, or equivalent.
- At least 5 years of Quality Assurance experience in commercial pharmaceuticals under GMP.
- Strong understanding of EU/FDA GMP requirements, regulatory dossiers, and release processes.
- Proven track record in pharmaceutical project management, ideally with complex supply chains & CMO/CLO management.
- Excellent stakeholder management skills, with the ability to work collaboratively in a global team environment.
- Fluent in English (spoken & written).
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