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An exciting opportunity is available for a motivated and detail-oriented Quality Specialist to join a Global Development Quality team. This role offers exposure to a wide range of investigational medicinal products, from small molecules to advanced immunotherapies, contributing directly to the delivery of life-saving treatments to patients.
Key Responsibilities:
* Perform final review of clinical batch records to ensure compliance with GMP and regulatory filings.
* Compile and approve data packs for Qualified Person (QP) release.
* Collaborate with global clinical supply chain teams and manufacturing sites (internal and external).
* Manage issue resolution and ensure timely documentation and communication.
* Maintain high standards of accuracy and compliance throughout the review process.
Qualifications & Skills:
Required:
* Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy).
* Strong attention to detail and organizational skills.
* Excellent communication and interpersonal abilities.
* Ability to work independently and manage multiple priorities.
Preferred:
* Prior experience in a QA or GMP-regulated environment.
* Familiarity with clinical manufacturing and regulatory compliance processes.
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