GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs.
We are hiring for QA Validation Specialist for the Sligo region.
- Management of validation, exception event, and change control processes.
- Creation/Review/Approval of various validation and qualification documents
- Generation/maintenance/execution of Project Validation Plans and schedules.
- Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
- Communicating with peers and management regarding activities in the area, including elevation of events or concerns
- QA support for validation investigations and implementation of corrective actions.
- Generation of validation protocols and final reports to cGMP standards.
- Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with client’s policies, FDA, European cGMP and GAMP standards
- Performing cross training within the team and training of new team members.
- Documenting all activities in line with cGMP requirements.
Education & Requirements
- A degree-level qualification in Science / Engineering discipline or equivalent knowledge and experience.
- 3 – 5years plus validation/ quality experience with strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical sector.
- Excellent interpersonal and communication skills.
- An ability to work independently, as well as collaboratively within a team in a dynamic, fast-paced environment.
- Collaborative Team Player.