[ref. r51679404] QA Validation Specialist_Permanent

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Application Details

Please review the Eligibility and requirements for an employment permit if you are unsure of your eligibility to apply for this vacancy.

1. 6087188720703;-7.92410802841187;Co. Tipperary ,

Designation/Service provider: 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.

• 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.
• Sector:

• Experienced [Non-Managerial]

Candidate Requirements

• Minimum Experienced Required (Years): 5
• Minimum Qualification:No Qualification

• Ability Skills:Skilled Trade(s), Technical IT
• Competency Skills:Time Management, Working on own Initiative