Job Description
We are seeking a highly motivated individual to join our Pharmaceutical organization based in Louth. This role offers the opportunity to make a tangible impact through project work.
Duties:
* Administrates event management systems, including reviewing and approving events and deviations.
* Manages batch records design and approval.
* Liaises with site change control systems.
* Approves and compiles validation protocols and reports.
* Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance.
* Coodinates and assists in preparing for regulatory and customer GMP inspections.
Requirements:
* Bachelor's degree in a scientific or technical discipline is required.
* Experience in quality within the biological and/or pharmaceutical industry.
* Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
This position requires someone who can apply GMP regulations and international guidelines to all aspects of the role. If you have the necessary skills and experience, we encourage you to apply.