Quality Assurance Specialist: GMP, CAPA & Audits Lead

Smart4 Sciences; Alton; On-site; GBP 42,000 - 60,000; Full time

Job summary

Smart4 Sciences in Alton is seeking a Quality Assurance Engineer/Specialist to ensure compliance across production and customer operations. The role involves coordinating audits, leading investigations into non-conformities, and managing change controls to uphold GMP standards.

You will review deviations, support new product introductions, and liaise with customers while representing the QA function. A degree in science/engineering and ISO13485 experience are desirable.

Qualifications

• Qualified internal auditor with hands-on QA experience in GMP-regulated environments.
• Strong knowledge of GMP, ISO13485 and quality systems.
• Experience applying problem-solving techniques to identify root causes and implement CAPAs.

Responsibilities

• Coordinate and manage the internal audit programme with planning, execution, reporting and CAPA follow-up.
• Lead investigations into non-conformities and quality issues, implementing effective corrective actions.
• Manage Change Control to ensure regulatory and operational compliance.
• Investigate customer quality issues and complaints with timely corrective actions.
• Review deviations and allocate actions for timely closure.
• Support new product introduction projects through line trials and inspections.

Skills

Internal auditor

Quality Assurance

GMP knowledge

Root cause analysis

QA collaboration

Education

Degree in science/engineering/manufacturing

ISO13485 knowledge

Tools

Change Control

CAPA

Deviations review

Job description

Smart4 Sciences in Alton is seeking a Quality Assurance Engineer/Specialist to ensure compliance across production and customer operations. The role involves coordinating audits, leading investigations into non-conformities, and managing change controls to uphold GMP standards.

You will review deviations, support new product introductions, and liaise with customers while representing the QA function. A degree in science/engineering and ISO13485 experience are desirable.