Job Overview
The Quality Assurance Specialist plays a vital role in ensuring the highest standards of quality across our operations. This includes overseeing all aspects of engineering activities, equipment qualification, and facility modifications to guarantee they meet EU GMP requirements.
Key Responsibilities:
* Ensure that all engineering activities align with EU GMP standards and are inspection-ready at all times.
* Provide oversight and guidance on equipment qualification, utility validation, facility modifications, and engineering change controls.
* Support the commissioning and qualification lifecycle, including document review and approval of protocols (IQ/OQ/PQ), risk assessments, and summary reports.
* Lead or support investigations related to engineering deviations, non-conformances, and CAPAs to ensure timely closure and root cause identification.
* Maintain and improve engineering quality processes, such as document control, calibration systems, and preventative maintenance compliance.
Required Skills and Qualifications:
* A degree in Engineering, Life Sciences, or a related technical discipline is required for this position.
* 5+ years' experience in a GMP-regulated pharmaceutical, biopharma, or medical device environment is essential.
* Strong knowledge of validation principles, engineering best practices, and regulatory requirements under GMP is necessary.
Benefits:
This role offers the opportunity to work with a talented team, contribute to the development of high-quality products, and grow professionally in a dynamic industry.
Others:
Applicants should possess excellent communication and problem-solving skills, with the ability to work effectively in a team environment.