|Sector||:||Engineering & Technical|
|Tel||:||094 900 3979|
Role of this position
- Process Validation against Corporate SOP/FDA/EMEA requirements.
- Accountable for writing, executing & reporting validation documentation (DQ / FAT / IQ / OQ / PQ / PPQ / pFMEA).
- Execution and documenting of process risk assessment / failure mode and effects analysis.
- Statistical analysis of data to determine process capability through Cpk and other statistical techniques.
- Performing of validation functional testing as required.
- Track and resolve exceptions during qualification activities.
- Participate in cross functional teams.
- Ensure all information is recorded correctly and compliant with GDP.
- Assist in execution of validation protocols.
- Development of project plans to validate processes
- Validation projects will be across a range of production areas which may include automation, filling, mixing, cleaning, software, utility and facility projects.
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- Min 3-5 year’s experience in validation in an automated/pharma manufacturing environment.
- In-depth knowledge of vvalidation processes.
- Knowledge of Pharma/Medical pproduct mmanufacturing, especially automated processes or filling operations.
- Project Management skills.
- Excellent interpersonal, communication & technical report writing skills
- Experience in process, software, filling and automation process validation.
- Experience in mixing & cleaning validation with understanding of associated chemistry and microbiology requirements.
- Experience with Minitab or similar stastical package.
Please call Louise Mulligan today for further information on 094 900 3979 or email: email@example.com CareerWise Recruitment -
IN SEARCH OF EXCELLENCE
CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Mayo, Cork, Shannon, Galway and Dublin