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15h Left Quality Specialist

4 weeks ago

Longford, Ireland Life Science Recruitment Full time
We're currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Louth. This is an excellent position for anyone who is interested in project work and making a tangible impact.

Duties

1. Carries out tasks related to the administration of event management systems including Review & Approval of Event and Deviations.
2. Carries out tasks related to the management of batch records design and approval.
3. Carries out tasks relating to the management of site change control systems.
4. Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
5. Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance.
6. Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.

Education & Experience

1. Bachelors Degree in a scientific/technical discipline required.
2. Experience in quality within the biological and/or pharmaceutical industry.
3. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.

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