• 12 Month Contract
  • Cork

QA Resources are looking for a number of contract QA Validation Specialists for an exciting project based in Cork.

Role and requirements:

  • Review of IQ/OQ/PQ protocols and reports for software, equipment and facilities and report on executed protocols, as required.
  • Develop validation protocols and reports to ensure compliance with regulatory requirements.
  • Assist in the management of the site Validation Master Plan and its timely execution.
  • Act as a site contact for vendors where required, including off-site meetings where applicable (e.g., F.A.T)
  • Provide QA support for equipment qualification. Review and approve protocols and reports.
  • Review and contribute to the development of User Requirement Specifications.
  • Provide a review and approval of all vendor supplied documentation.
  • Author documents that ensure cGMP compliance, such as investigations, CAPAs, reports and forms.
  • Perform other related duties or projects as assigned.

Experience:

  • Bachelor’s Degree required in a scientific or engineering discipline.
  • Minimum of 2+ years’ experience in the pharmaceutical industry with excellent working knowledge of cGMP
  • Experienced in QA Validation activities
  • Extensive experience on writing and approving cGMP documentation
  • Good communicator both verbally and written with strong interpersonal and excellent organizational skills.
  • Software, Process, Cleaning, Equipment, Facilities, and Utilities Validation knowledge and /or experience is preferable.

 

Interested candidates should submit an updated CV to enquiries@qaresources.com

To apply for this job email your details to enquiries@qaresources.com.