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.