Urgent! QA Validation Specialist Position in Cashel - Test Triangle
Designation/Service provider QA Validation Specialist Reporting to whom Senior Manager QA Ops 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.
Bachelor’s degree in Science or Engineering discipline
5+ years experience in pharmaceutical QA Validation roles
Eligibility to work in Ireland
5+ years
Technical Expertise Equipment / Systems / Facilities / Utilities Qualification (IQ, OQ, PQ) Computerised Systems Validation (CSV) Validation lifecycle management (VMPs, protocols, reports) Calibration and Preventive Maintenance (PM) processes Risk assessment and deviation investigation Change control and CAPA management Data Integrity and Good Documentation Practice (GDP) Knowledge of GMP, FDA, EMA, HPRA regulations Validation Master Plan (VMP) preparation and execution Audit readiness and regulatory inspection support
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Unlock Your QA Validation Potential: Insight & Career Growth Guide
Real-time QA Validation Jobs Trends in Cashel, Ireland (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for QA Validation in Cashel, Ireland using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 287 jobs in Ireland and 3 jobs in Cashel. This comprehensive analysis highlights market share and opportunities for professionals in QA Validation roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Test Triangle is currently hiring and seeking a QA Validation Specialist to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Test Triangle adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a QA Validation Specialist Jobs Ireland varies, but the pay scale is rated "Standard" in Cashel. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for QA Validation Specialist typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your QA Validation Specialist interview at Test Triangle, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Test Triangle's products or services and be prepared to discuss how you can contribute to their success.
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