About Your New Employer
- Our Client, a world leader in delivering digital transformation solutions to Life Sciences. Through their knowledge and expertise in Automation, MES & Digital, they deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance.
- The companies specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions, covering all IT, OT and IoT applications, infrastructures and services.
- Our client maintains a Managed Service on the site, supporting Automation, MED, IT functions acorss operational and project levels.
About Your New Role
- You will manage Computer System Validation projects from software install to business release
- You will be required to generate computer system validation documentation in accordance with site procedures and GMP guidelines
- You will execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
- Work with the business to identify and implement procedural controls to mitigate issues found during testing
- Your role will involve you initiating and implementing Change Control activities in accordance with Quality Standards and Practices
- Determine solutions or recommendations for changes and/or improvements
- Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
What Skills You Need
- Minimum 3-5 years’ experience validating IT applications
- Past proven experience engaging business users to ensure that appropriate business needs are clearly defined, communicated and delivered at or above expectations
- Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally
- Experience of server and workstation platforms and working in a Win 10 environment
- Experience of SQL databases is an advantage
- Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
- Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.
What’s on Offer
- Competitive Salary DOE
- Hourly Rate Optional
For a confidential discussion on this or any other current job opportunity please contact Loren Pey on 021 4847137 / lpey at sigmar.ie
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