GerTEK Project Management & Technical Services are hiring for an experienced QA Validation Professional to join our team.
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
Schedule:
* 8 hour shift
Work Location: In person
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