Quality Assurance Specialist
1 week ago
The role of a Quality Assurance Specialist is crucial in ensuring that all site equipment, utilities, processes, and software are validated and maintained to meet external regulatory, quality, and compliance requirements.
Key Responsibilities:
- Develop and implement the site validation master plan, oversee the execution of project validation plans and schedules, and ensure compliance with cGMP standards.
- Investigate and implement corrective actions, generate and review various quality documents and test data.
- Manage validation, exception event, and change control processes, as well as maintain tracking of validation equipment.
- Document all activities according to cGMP requirements and update validation procedures and job instructions to reflect current best practices.
Requirements:
- A qualification and/or degree in an engineering or scientific discipline.
- At least 3 years' experience in validation/quality, preferably in medical device plastics processing, moulding, or assembly operations.
- Strong knowledge of cGMP and regulatory requirements relating to the medical device industry.
This role offers a unique opportunity for career growth and development in a dynamic environment. The successful candidate will have the chance to work on challenging projects, develop new skills, and contribute to the success of the organization.
We Offer:
- Competitive salary and benefits package.
- Ongoing training and development opportunities.
- A collaborative and supportive work environment.
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