Pharmaceutical Supply Chain Quality Assurance Specialist

2 weeks ago

Galway, Galway, Ireland beBeeQuality Full time €80,000 - €110,000
Job Description

As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of clinical supply chain operations. This includes serving as a Responsible Person (RP) under a Wholesale Distribution Authorisation (WDA) for Pre-Approval Access, leading and supporting Good Manufacturing Practice (GMP)/Good Distribution Practice (GDP) inspections and audits, advising stakeholders on quality improvements and risk mitigation, and maintaining and updating the Site Master File and Manufacturer's Authorisation.

Required Skills and Qualifications

To be successful in this role, you will need to have a degree in science, engineering, or a related discipline, and be eligible to act as a Qualified Person (QP) under EU regulations. Experience as a Responsible Person (RP) under a WDA is preferred, and at least 10 years of experience in the pharmaceutical/biopharma industry is required.

Benefits

This position offers the opportunity to work in a dynamic and growing industry, with a focus on quality and compliance. You will have the chance to develop your skills and knowledge, and contribute to the success of our organization.

Others

Stay up-to-date with global regulatory changes and integrate them into quality systems.

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