We are seeking a skilled professional to join our Pharmaceutical organization based in Louth, Ireland.
This role offers an excellent opportunity for individuals who want to work on project-based tasks and contribute to tangible results.
Duties
* Administer event management systems, reviewing and approving events and deviations as necessary.
* Manage batch records design and approval processes.
* Oversee site change control systems.
* Approve and compile validation protocols and reports, including analytical, cleaning, computer, process, equipment, and other relevant types.
* Review and approve Standard Operating Procedures (SOPs), work instructions, and forms from other departments on behalf of Quality Assurance.
* Coordinate and assist with preparation for regulatory and customer Good Manufacturing Practice (GMP) inspections at the site.
Requirements
* Bachelor's Degree in a scientific or technical discipline is required.
* Experience in quality within the biological and/or pharmaceutical industry is essential.
* Familiarity with FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals is necessary, along with the ability to apply GMP regulations and international guidelines to all aspects of the position.
Estimated Salary
The estimated salary for this position is £35,000 - £50,000 per annum, depending on experience and qualifications.