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Senior Validation Specialist
2 weeks ago
At Team Horizon, we are seeking a skilled Senior Validation Specialist to join our team for an 18-month contract. As part of our client's team, you will be responsible for coordinating the development and maintenance of the site validation program. This role is ideal for individuals with strong communication skills and experience in cGMP regulated environments.
Responsibilities:
- Coordinate the validation and qualification of site equipment, utilities, processes, and software in compliance with policies, FDA, European cGMP, and GAMP standards.
- Generate validation and qualification protocols and final reports to cGMP standards.
- Manage validation investigations and implement corrective actions.
- Create, review, and approve qualification documents and test data.
- Maintain and track engineering equipment, if applicable.
Requirements:
- Minimum 3 years of validation experience in medical device plastics processing, moulding, or assembly operations.
- A minimum of 3 years' experience in a cGMP regulated environment.
- Strong communication, presentation, and troubleshooting skills required.
- Effective interpersonal and organizational skills.
- Capable of prioritizing work and multitasking.