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 abilitiesRequired:

• 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 GDPrequirements
• Good communicator both verbally and written with strong interpersonaland excellent organizational skills
• Strong problems solving skills combined with the ability to troubleshoot 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