Senior Quality Assurance Auditor
On-site · Macclesfield, England, United Kingdom
Job Summary
Senior QA Auditor responsible for ensuring that organisational processes and services comply with quality standards and regulatory requirements. Role focuses on conducting audits, identifying gaps, and driving continuous improvement across quality systems. Responsibilities include planning and performing study, facility and process audits in compliance with SOPs; communicating audit outcomes to site management; maintaining the CAPA system; preparing QA statements and archiving audit reports; approving GMP documentation; participating in validation activities; reviewing SOPs for consistency; managing supplier assessments; and providing guidance and training on quality-related issues. The role supports QA management in hosting sponsor and monitoring authority inspections, and requires willingness to travel. Strong knowledge of GLP, GCP, GMP, ISO environments, and national regulations, with the ability to work independently and collaboratively in a team, and excellent attention to detail and communication skills.
Required Qualifications
- Minimum 2 years’ auditing experience in GLP, GCP, GMP, or ISO environments
- Degree in a relevant natural science
- Proficient in written and spoken English
- Strong attention to detail, communication, problem-solving, and organisational skills
- Able to work independently and collaborate effectively in a team
- Willing to travel as needed
- Submit CV/Resume in English
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