Job Title
CSV Validation Engineer
Location: Co.
Tipperary
Application Details
In order to work in Ireland a non-EEA National, unless they are exempted, must hold a valid employment permit.
Please review the Eligibility and requirements for an employment permit if you are unsure of your eligibility to apply for this vacancy.
Job Description
QA Validation role to ensure qualification of equipment, computerised systems, facilities and utilities is performed in compliance with regulatory requirements, company policy and procedures.
Responsibilities
Review qualification / re-qualification and validation activity of equipment, system, facility, and plant utilities.
Support execution of qualification / re-qualification and validation activity.
Review and approval of project validation plans.
Coordinate with manufacturing / engineering personnel for respective qualification / validation activities for timely completion.
Investigate deficiencies related with qualification activities and determine corrective actions.
Review SOPs and drawings as related to validation.
Review and approval of calibration and PM activities (e.g., schedules) and work orders as related to validation.
Review and approval of studies/risk assessments/investigations related to qualification.
Participate in investigations that may impact the qualified state of equipment, systems, facilities or utilities.
Qualifications
Science graduate with minimum 5-year experience in pharmaceutical industry accredited by HPRA and FDA.
Career Level
Experienced (Non-Managerial)
Candidate Requirements
Essential
Minimum 5 years experience.
No qualification required.
Desirable
Skill in trade(s) or technical IT.
Teamwork, time management, initiative.
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