Quality Assurance Auditor

Synexa Life Sciences; Macclesfield; On-site; GBP 42,000 - 54,000; Full time

Job summary

Synexa Life Sciences invites applications for a QA Auditor to uphold quality and regulatory compliance across the organisation. The role involves audits, CAPA management, documentation reviews, and inspection support to ensure adherence to SOPs and industry standards while driving continuous improvement.

Key responsibilities include maintaining the quality system, planning audits, reporting audit outcomes, and guiding staff on quality-related issues.

Qualifications

• Minimum 2 years’ experience in GLP, GCP, GMP, or ISO environments.
• Degree in a relevant natural science.
• Understanding of national laws and relevant regulations and guidelines and SOPs and site related functions.
• 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.
• Proactive and decisive with a scientific background (desirable).
• Willing to travel as needed.

Responsibilities

• Follow and where applicable implement appropriate laws, regulatory guidelines, SOPs, Study Plans.
• Participating in the maintenance of the quality system.
• Forecast, monitor and control the work volume within QAU.
• Plan and organise all activities within the QAU.
• Schedule and perform study, facility and process audits in compliance with SOPs.
• Communicate the audit outcome to relevant personnel and site management and ensure that audit responses are appropriate.
• To maintain the CAPA system and follow up CAPA actions.
• Prepare and sign QA statements for inclusion in reports in accordance with SOPs.
• Submit audit reports for archiving in accordance with the applicable SOP.
• To approve GMP documentation where applicable.
• To participate in computerized system validation team where applicable.
• Review Standard Operating Procedures for consistency and compliance and maintaining QA SOPs.
• Manage and conduct assessment of key company suppliers as requested by management to ensure compliance with regulatory guidelines.
• Provide guidance, training and consultation in quality-related issues.
• Support QA Manager in management and hosting of sponsor and monitoring authority inspections.
• Observe appropriate regulatory guidelines, SOPs, policies and study documentation.
• Working in accordance with standard operating procedures (SOPs) by authoring, reviewing, and maintaining SOPs, guidance documents, and policies, as well as providing training and support to staff.

Skills

Attention to detail

Communication

Problem solving

Organisational skills

Independent work

Team collaboration

Travel willingness

English proficiency

Education

Degree in natural science

Job description

The QA Auditor plays a key role in maintaining quality and regulatory compliance across the organisation. Responsible for conducting audits, managing CAPAs, reviewing quality documentation, and supporting inspections, the role helps ensure adherence to regulatory requirements, SOPs, and industry standards while driving continuous improvement and quality excellence.

Key Responsibilities

• Follow and where applicable implement appropriate laws, regulatory guidelines, SOPs, Study Plans.
• Participating in the maintenance of the quality system.
• Forecast, monitor and control the work volume within QAU.
• Plan and organise all activities within the QAU.
• Schedule and perform study, facility and process audits in compliance with SOPs.
• Communicate the audit outcome to relevant personnel and site management and ensure that audit responses are appropriate.
• To maintain the CAPA system and follow up CAPA actions.
• Prepare and sign QA statements for inclusion in reports in accordance with SOPs.
• Submit audit reports for archiving in accordance with the applicable SOP.
• To approve GMP documentation where applicable.
• To participate in computerized system validation team where applicable.
• Review Standard Operating Procedures for consistency and compliance and maintaining QA SOPs.
• Manage and conduct assessment of key company suppliers as requested by management to ensure compliance with regulatory guidelines.
• Provide guidance, training and consultation in quality-related issues.
• Support QA Manager in management and hosting of sponsor and monitoring authority inspections.
• Observe appropriate regulatory guidelines, SOPs, policies and study documentation.
• Working in accordance with standard operating procedures (SOPs) by authoring, reviewing, and maintaining SOPs, guidance documents, and policies, as well as providing training and support to staff.

Qualifications & Experience

Required:

• Minimum 2 years’ experience in GLP, GCP, GMP, or ISO environments.
• Degree in a relevant natural science.
• Understanding of national laws and relevant regulations and guidelines and SOPs and site related functions.
• 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.
• Proactive and decisive with a scientific background (desirable).
• Willing to travel as needed.