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Details

Quality Specialist - Remediation


Reference:SMC359534 Location: Louth
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Engineer

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

• 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 where appropriate 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
• Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.

Education & Experience

• 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 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.