QA Validation Specialist_Permanent

Summary: QA Validation role to ensure Qualification of Equipment / Computerised Systems / Facilities and Utilities is performed in compliance with regulatory requirements, company policy and procedures. Support to production / engineering to ensure the qualified state of equipment, systems, facilities and utilities are maintained.

Job Duties:

· Review and approval of Qualification / Re-Qualification protocols (IQ, OQ, PQ) for Equipment / Systems / Facility and Plant utilities as QA Validation.

· Review and contribute to the development of User Requirement Specifications.

· Support execution of Qualification / Re-Qualification activity including walkdowns of drawings and areas.

· Interact with vendors where required, including off-site meetings where applicable (e.g., F.A.T)

· Review and approval of drawing, SOPs and support documents related to qualification activities.

· Co-ordinate and lead communication with manufacturing / engineering personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.

· Participate as a SME providing quality oversight and regulatory advice for qualification activities including CSV qualification and data integrity.

· Provide QA Validation support for Laboratory equipment qualification. Review and approve protocols and reports.

· Lead investigation of any deficiencies related to qualification activities and determine corrective actions.

· Generate and execute project validation plans and validation master plans.

· Prepare and review of Policy Documents and SOPs related to validation.

· Review and approval of calibration and PM activities (e.g. schedules) and Work orders.

· Tracking and Mgt of Annual Validation Schedule and Periodic Requalification activities.

· Preparation, execution and support of studies / risk assessments / investigations related to Qualification

· Participate in any investigations that may impact the qualified state of equipment, systems, facilities or utilities

· Supports compliance and maintains audit readiness for Validation. Support and participation in regulatory audits (FDA and HPRA)

· Provides feedback on systems to promote continuous improvement and enhancement of compliance. Identify opportunities to improve efficiency within Validation and manage KPI for reporting at Mgt Review.

· Assist in conducting internal self-inspections and external audits as appropriate.

· Assist in maintaining the site validation document archive system.

· Perform assigned tasks in accordance with procedural requirements and scheduled timelines. Notify supervisor and other impacted stakeholders if procedural requirements or timelines are not being met.

· Carry out and assist in the on-going training of new and existing personnel, as appropriate.

· Perform other related duties or projects assigned

Qualifications, Skills and abilities Required:

· Bachelor’s degree in science or engineering discipline with more than 5 Years experience working in a Pharmaceutical Industry in QA Validation role.

· Clear Understanding of European and FDA regulations related to Qualification, Validation and Computerised Systems. Familiar with Data Integrity and GDP requirements

· Good communicator both verbally and written with strong interpersonal and excellent organizational skills

· Strong problems solving skills combined with the ability to trouble shoot with knowledge of FDA/EMA regulatory requirements essential.

· Excellent Protocol / Report writing skills are required

· Ability to provide direction and assign work to meet goals and deadline

· Must be eligible to work in Ireland.