GerTEK Project Management & Technical Services are hiring for an experienced QA Validation Professional to join our team.
The QA Validation Engineer is responsible for the Coordination / direction and active participation in the validation and qualification of equipment, utilities, processes and software in compliance with clients policies, FDA, European cGMP and GAMP standards.
Responsibilities
- 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
Requirements
- 2+ years plus validation/Quality experience in sterile/aseptic environment especially in the commissioning and qualification area.
- 2+ years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical / medical device 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.
Job Type: Full-time
Work authorisation:
Work Location: In person
