Quality Assurance Specialist, CMC
2 weeks ago
About the Role
We are seeking a highly skilled Quality Assurance Specialist to join our CMC Development team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.
Key Responsibilities
- Review batch records and ensure compliance with regulatory requirements
- Conduct QA assessments of deviations, change controls, and laboratory deviations
- Approve master batch records and ensure their accuracy
- Handle complaints and ensure timely resolution
- Contribute to vendor oversight and re-evaluations
Requirements
- Master's degree in pharmacy, chemistry, biology, or a related field
- Minimum 2 years of experience in a GMP regulated environment, preferably in manufacturing, quality control, or quality assurance
- Knowledge of CMC regulations and guidelines is an advantage
- Fluency in English is required
What We Offer
Lundbeck offers a dynamic and collaborative work environment, with opportunities for professional growth and development. We are committed to building a diverse and inclusive team, and we welcome applications from candidates with a wide range of backgrounds and experiences.
How to Apply
If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity. Please upload your CV and a brief statement outlining your motivation for applying.
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