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Job Title

Validation Engineer

Employer

Eflexes

Location

Limerick , Clare

Description

Responsibilities: Reporting to the Department Manager you generate validation documentation including risk assessments, traceability matrix and validation plan/reports. Development and review of software validation test protocols including FAT & SAT protocols. Participate in FAT and SAT protocol execution, as necessary. Collate and organise all qualification files for the project (including Test protocols, Reports etc.) Document, Investigate and report all deviations/exceptions during the qualification activities. Co-ordinate qualification activities with contractors and vendors as required. Efficient management of priorities. Travel may be required. Key Skills & Attributes. Proven track record in developing validation document for the pharmaceutical and medical device industry. Proactive and solutions focused with good organisational skills · Ability to multitask and manage multiple projects simultaneously. Excellent communication skills. Excellent technical skills including proficiency in Word, Excel, PowerPoint & MS Project. Qualifications. 3-5 years’ experience in a validation role in either Medical Device or Pharmaceutical Industry. Knowledge of Computer System Validation including GAMP 5, 21 CFR Part 11 and cGMP requirements. BSc or BEng Degree. This job originally appeared on RecruitIreland.com.

Date Added

2440 days ago

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