Job Overview:
A Quality Assurance and Engineering professional is required to join a leading biopharmaceutical company.
The ideal candidate will be responsible for ensuring engineering activities are carried out in compliance with GMP and site quality engineering standards.
Key Responsibilities:
* Provide oversight for equipment qualification, utility validation, facility modifications, and engineering change controls.
* Support the commissioning and qualification (C&Q) 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 ensuring timely closure and root cause identification.
* Participate in cross-functional project teams for new equipment introduction, process improvements, and site upgrades, ensuring quality is embedded throughout.
Requirements:
* Strong understanding of QA expectations (deviations, CAPAs, change control), GMP, and GDP.
* Proven ability to work effectively on their own initiative as well as effectively contributing to the team environment.
* Experience working in a matrix role bridging Engineering and Quality departments.
* Knowledge of ISPE Baseline Guides, GAMP 5, and data integrity best practices.
Benefits:
* Competitive salary and comprehensive benefits package.
* Opportunities for professional development and career advancement.
* A supportive and inclusive work environment that values innovation and excellence.
What's Next:
Apply now by clicking the "Apply Now" button or contact Ross Keyes at Sigmar Recruitment.