Quality Specialist – CSV
A global Bio-Pharmaceutical company based in Athlone require a Quality Assurance Specialist who is a Subject Matter Expert in CSV within their projects team. This team undertake projects relating to facility, utility, equipment and computer systems. Projects include; facility expansion, upgrade and maintenance of systems, equipment and utilities. This role reports to the Associate Director or Quality Assurance.
The successful Quality Specialist – CSV will:
- Function as Quality Technical Lead with special responsibility for projects relating to computerised system and process automation control systems.
- Function as Quality Technical Lead on projects relating to facility, utility and equipment changes/upgrades in line with strategic objectives.
- Serve as Quality Technical lead for qualification/validation based activities to support the above in line with current guidance and site/global procedures.
- Participate in and support risk management activities in line with relevant guidance and best industry practice.
- Provide input and guidance to deviation management activities resulting in appropriate root cause analysis and relevant CAPA actions.
- Provide leadership, guidance and support to data integrity initiatives and systems.
- A third level qualification in science, engineering, information technology or suitably related field is required.
- 8 years’ experience in the pharmaceutical or related industry preferably in a Quality or Validation related role is desirable.
- Previous experience in CSV or related area is essential.
For more information contact Kristine Reynolds on +353 91 782112
Salary: On Application