Ger TEK 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 c GMP and GAMP standards.
Responsibilities To coordinate the development and maintenance of the site validation program and ensure clien and external regulatory, quality, and compliance requirements are met.
Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.
Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with client policies, FDA, European c GMP and GAMP standards.
Generation/maintenance/execution of the Site Validation Master Plan.
Generation/maintenance/execution of Project Validation Plans and schedules.
Generation of validation protocols and final reports to c GMP standards.
Generation of validation investigations and implementation of corrective actions.
Creation/Review/Approval of various quality documents and test data.
Management of validation, exception event, and change control processes.
Maintenance and tracking of validation equipment, if applicable.
Completing all required training before executing a task.
Documenting all activities in line with c GMP requirements.
Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
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.
Maintaining the overall c GMP compliance of the production areas.
Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
Requirements Qualification and/or degree in engineering or scientific discipline.
Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations or similar industry.
3 years plus of knowledge of c GMP and regulatory requirements relating to the medical device industry.
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