-
Job Description
QA Validation Engineer sought for dynamic team to manage validation processes, create documents, and ensure compliance with c GMP standards.
Ger TEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with life science & technology companies to deliver strategic projects with technically strong personnel.
Key Responsibilities:
- Management of validation, exception event, and change control processes.
- Creation/Review/Approval of 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.
- QA support for validation investigations and implementation of corrective actions.
- Generation of validation protocols and final reports to c GMP standards.
- Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software.
- Performing cross training within the team and training of new team members.
- Documenting all activities in line with c GMP requirements.
Requirements:
- A degree-level qualification in Science / Engineering discipline or equivalent knowledge and experience.
- 3 - 5 years plus validation/ quality experience with strong knowledge of c GMP and regulatory requirements.
- Excellent interpersonal and communication skills.
- An ability to work independently, as well as collaboratively within a team in a dynamic, fast-paced environment.
We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment.