Quality Assurance Validation Specialist

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.