QA Validation Engineer
GerTEK Project Management & Technical Services is one of Ireland’s leading Project Management and Technical Service companies. We are hiring for an experienced QA Validation Engineer to join our team.
The QA Validation Engineer is responsible for coordination / direction and active participation in the QA validation and qualification of equipment, utilities, processes and software in compliance with clients policies, FDA, European cGMP and GAMP standards.
- Generation/Maintenance/Execution of Project Validation Plans and schedules.
- Generation of validation protocols and final reports to cGMP standards.
- QA support for validation investigations and implementation of corrective actions.
- Creation/Review/Approval of various validation and qualification documents
- Management of validation, exception event, and change control processes.
- Documenting all activities in line with cGMP requirements.
- Performing cross training within the team and training of new team members.
- Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
- Coordinating activities to maximize the effectiveness of all of the team members.
- Communicating with peers and management regarding activities in the area, including elevation of events or concerns
- A third level qualification in Science, Engineering, or a relevant Quality discipline.
- 3-5 years plus Validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area.
- 3-5 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry
- Strong communication (written and oral), presentation and troubleshooting skill required
- Effective interpersonal and organizational skills.
- Ability to work well both independently and in a team environment.
- Capable of prioritizing work and multitasking.