Lab Validation Specialist
Brightwater
Waterford
This role brings the opportunity to contribute to the development of the Instrument Centre Of Excellence at one of Waterford`s leading Pharma employers. You will assist in the validation of new Laboratory instruments and software packages, building a library of protocols that will be available for global use. An excellent salary and benefits package is on offer for the right candidate. Principal Responsibilities. Implementation and administration of validated laboratory computer systems. Planning, executing and documenting the full validation lifecycle for the first time qualification of new computerized laboratory equipment in a cGMP regulated environment. Building and maintaining a library of validation packages for Laboratory Equipment. Evaluate systems/equipment in accordance with cGMPs, Part 11, and other regulatory requirements.Ensure system compliance with Data Integrity standards and assist with remediation if required. Provide 2nd Level Support to QC on Instrument Issues. Train laboratory personnel on new software applications as part of first time qualification projects. Minimum Qualifications/Experience: BSc. In Science, Computer Science, Engineering or related discipline with 3-5 years related experience. Computer and/or Computerised Equipment Validation experience. Project Management experience preferred. Knowledge, Skills & Experience : Excellent knowledge of USP, cGMPs, and cGLPs. Excellent knowledge of QC laboratory practices in a pharmaceutical Quality Control environment. Excellent computer skills including MS Office, Windows. Knowledge of current Data Integrity Guidance. Strong communication skills both verbally and written. Ability to work independently or in a team environment through cooperative participation in department and interdepartmental teams. Able to train others on new applications as needed. Excellent interpersonal skills. Excellent multitasking skills, handling multiple projects at one time. Ability to travel is a requirement of this role and flexibility with regard to working hours. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.
2439 days ago