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.