Job Opportunity
This is an exciting opportunity with a Pharmaceutical organization based in Louth. It is ideal for individuals who are interested in project work and making a tangible impact.
Duties
* Carries out tasks related to the administration of event management systems, including Review & Approval of Event and Deviations.
* Carries out tasks related to the management of batch records design and approval.
* Carries out tasks relating to the management of site change control systems.
* Approves and compiles validation protocols and reports as appropriate (analytical, cleaning, computer, process, equipment, etc.).
* Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance.
* Co-ordinates 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. Ability to apply GMP regulations and other international guidelines to all aspects of the position.