Job Role:
We are seeking a skilled Validation Specialist to join our team.
The ideal candidate will have experience in creating and executing validation documentation, as well as coordinating validation activities for various systems and processes within a quality management system.
Key Responsibilities:
* Develop and implement validation plans, protocols, reports, and amendments to ensure compliance with regulatory requirements.
* Create quality documentation related to validation activities.
* Liaise with cross-functional teams to provide validation inputs and initiatives.
* Collaborate with external vendors for validation plans and requirements.
* Develop validation projects and master validation plans.
* Support the implementation of company policies and Good Manufacturing Practices (GMP).
* Ensure ongoing compliance with GMP in all practices and recording of events and processes.
* Participate in and drive quality GMP audits.
Requirements:
* Bachelor's degree in Engineering or Science discipline.
* At least 3-5 years' experience in a validation or quality engineering role.
* Strong working knowledge of process validation and capability.
* Familiarity with validation and quality principles and practices, including EudraLex, ISO13485, ISO14644, GAMP5, and FDA Pharma and medical devices regulations.
* Ability to work in a cross-functional team environment with excellent initiative, decision-making, and drive for achieving results.
* Excellent technical report writing, time management, computer, and presentation skills.
Benefits:
This role offers a competitive salary and opportunities for career growth and development.
About the Role:
This is an exciting opportunity to join a dynamic team and contribute to the success of our organization. If you are a motivated and detail-oriented individual with a passion for validation and quality, we encourage you to apply.