Quality Assurance Validation Specialist

  • Contract
  • Dublin

Website Ref:TPM04184

Summary:
Our client is a global pharmaceutical company with a facility in Dublin. They are looking for a QA Validation Specialist to Support validation projects working with project managers, to ensure that all proposed projects have all QA requirements in place.

Responsibilities:

  • Assessment of changes for GMP compliance for facilities, utilities, lab and manufacturing equipment and computer systems.
  • Review of master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
  • Actively contribute to continuous improvement initiatives including lean ways of working.
  • Preparation, review and approval of GMP documentation.
  • Reviews, edits and approves change control and SOPs.
  • Collaborates with functional departments to resolve issues.

Qualifications & Experience:

  • Min of BSc/BEng in Chemistry, Engineering or a science-related discipline with at least 2 years pharmaceutical experience ideally in a QA role.
  • Preferably with experience in change control/documentation management, good manufacturing practices.
  • Knowledge / appreciation of other site operations such as QC, Operations, Engineering, IT.
  • Some experience in Operational Excellence or project management would be desirable.
  • Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.

To apply for this job email your details to orla.daly@tandempm.ie.