Description:
A leading recruitment agency is pleased to partner with a distinguished client in the search for a Quality Engineer (Projects). This exciting opportunity places an experienced professional at the forefront of quality assurance for innovative product introductions and manufacturing excellence. With a focus on shaping processes and ensuring compliance within a GMP-regulated environment, this role provides a pivotal career opportunity for a skilled engineer.
Key Responsibilities:
- Validation Leadership:
- Drive compliance with validation requirements for new product introductions.
- Define and characterize process, product, and test method validation requirements.
- Develop, review, and approve Master Validation Plans, protocols, and reports.
- Development Support:
- Provide robust QA support during production line development and ramp-up, with a focus on risk mitigation.
- Offer quality expertise to ensure production lines adhere to cGMP standards, including procedure approvals, FMEAs, and cleanroom practices.
- Change and Quality Control:
- Review and approve change requests related to product, process, and quality system updates.
- Implement appropriate statistical techniques to monitor process performance, such as SPC, CpK analysis, and sampling methods.
- Provide expert guidance on quality-related issues, including non-conformances, CAPA, regulatory compliance, and statistical methodologies.
Education & Experience Requirements:
- A Bachelor of Science degree in Engineering or Technology (minimum requirement).
- A minimum of 3-4 years of experience in a manufacturing or equivalent environment, with direct experience in Quality Assurance (preferably within a GMP-regulated setting).