Quality Assurance Engineer/Specialist - Alton - Office Based
I am currently working with a leading CDMO manufacturing business based in Alton, supporting the pharmaceutical, medical device, cosmetics, and nutritional sectors. This is an excellent opportunity for an experienced Quality Assurance professional to join a fast-paced environment and contribute to ensuring compliance across production and customer operations.
Key responsibilities for the Quality Assurance Engineer/Specialist
- Coordinate and manage the internal audit programme, including planning, execution, reporting, and follow-up of corrective actions.
- Lead investigations into non-conformities and quality issues, applying problem-solving techniques to identify root causes and implement effective CAPAs.
- Manage the Change Control process to ensure regulatory and operational compliance.
- Investigate customer quality issues and consumer complaints, providing timely responses and corrective actions.
- Review and complete deviations, allocating actions to relevant teams and ensuring closure.
- Support new product introduction projects, including line trials, capability studies, and product inspections to meet customer specifications.
- Oversee QA validation team operations, including workload allocation and performance reviews.
- Review and sign off packing specifications and support with PQR reporting.
- Liaise with customers and attend meetings to represent the QA function.
Requirements for the Quality Assurance Engineer/Specialist
- Qualified and experienced internal auditor.
- Strong background in Quality Assurance within GMP-regulated environments (pharma, medical device, cosmetics).
- Good knowledge of quality improvement tools and problem-solving techniques.
- Ability to manage multiple priorities, work under pressure, and communicate effectively across all levels.
- Degree in science, engineering, or manufacturing discipline desirable.
- Experience with ISO13485 and GMP compliance advantageous.
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Quality Assurance Specialist in Alton employer: Smart4 Sciences
Join our dynamic team as a Shift Maintenance Engineer in Huddersfield, where we prioritise employee growth and development within the pharmaceutical manufacturing sector. Our supportive work culture fosters collaboration and innovation, offering competitive benefits and opportunities for skill enhancement in a regulated environment. Experience the unique advantage of working in a state-of-the-art facility that values your contributions and promotes a healthy work-life balance.
