Description
This is an immediate position with a leading company based in the South West of Ireland.Role Requirements:
Good knowledge of Computer Systems Validation including GAMP, Delta V and 21 CFR part 11.
Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations.
Champion the validation system including maintenance and continual improvement of the validation process in line with regulations and industry best practise.
Provide manufacturing quality engineering support for new product introductions and product changes to improve quality through improved processes and process control.
Provide manufacturing quality engineering support for current business to improve quality through improved manufacturing processes and process control.
Effective and efficient execution of validation and other projects. Achieve key project deliverables on time and within budget.
Champion structured approach to problem solving within the organisation using cross-functional teams and six - sigma methodology.
Lead and or participate in CAPA and other cross functional improvement teams to drive manufacturing quality improvements.
Maintain the plants calibration system and equipment calibrations as assigned.
Investigate, trouble shoot, disposition and report on validation failures, system failures, non conforming products and other product defects. Champion a structured approach to problem solving within process improvement teams.
Maintain and report on quality trending data as assigned.
Investigate, report on, and respond to customer complaints as assigned.
Person Specification:
A primary degree in engineering or equivalent.
A minimum of 5 years in a technical role, min 3 years medical device/pharmaceutical and/or API manufacturing experience.
Self starter with good inter-personal skills. Ability to multi-task is essential.
S/he should have strong analytical communication, organisational and influencing skills.
Excellent project management skills, setting realistic objectives and delivering
Energetic and driven self-starter, with good communication and influencing skills and the ability to effectively simultaneously manage a wide range of diverse activities.
Previous cleanroom, euipment and process validation experience.
If you would like to apply for the position please contact Sarah Irvine immediately on . We also offer €200 worth of vouchers for any successful referrals so if you know anyone who is looking please feel free to get in touch.