QA Validation Specialist

Team Horizon is seeking a Validation Engineer for our client’s manufacturing facility in Athlone. The QA Validation Specialist performs review and approval activities to support validation activities across cGMP commercial and clinical requirements for the Facility. The responsibilities will include performing review and approval of validation documents such as policies, master plans, procedures, specifications, investigations, protocols and reports

Why you should apply:

• Opportunity to leverage your expertise and add value to a broad range of significant projects across the site


• Join a company who are driven to continuously innovate and create meaningful value in patients lives 

What you will be doing:

• Maintenance of a strong Quality culture throughout the project through operational activities.


• Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.


• Lead and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations.


• Participate in verification quality risk assessments and provide quality oversight to ensure


• Verification quality risk assessments are effectively maintained/controlled.


• Ensure and participate in the Quality Assurance support to internal manufacturing and technical
  groups.


• Review and approval of functional area documentation (SOP, Work Instructions,
  Criticality Assessments, technical report and protocols).


• Authoring, review and approval of QA validation -related procedures.


• Review and approve Validation protocols as required. (Examples include cleaning, process, and method validation).


• Support the vendor quality management programme.


• Complete Audits as required.


• Develop and report quality metrics for validation/verification.


• Provide quality oversight of calibration and preventative maintenance criticality assessments as required.


• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.

What you need to apply:

• Primary Degree in Science


• 3-5 years’ experience in Quality/validation environment.


• Drug Product / Drug Substance experience


• Excellent attention to detail / Good communication, teamwork and problem-solving skills


• The duties of this role are generally conducted in an office environment and in a pharmaceutical manufacturing environment.