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
