Job Summary
This is an exciting opportunity with a Pharmaceutical organization based in Louth. It is ideal for those interested in project work and making a tangible impact.
Key Responsibilities
* Carries out tasks related to the administration of event management systems including Review & Approval of Event and Deviations.
* Manages batch records design and approval.
* Manages site change control systems.
* Approves and compiles validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
* Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance.
* Coordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
Requirements
* Bachelors Degree in a scientific/technical discipline required.
* Experience in quality within the biological and/or pharmaceutical industry.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.