QA Validation Specialist

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:

Bachelors 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.