At a Glance
- Tasks: Ensure quality and compliance through audits and documentation management.
- Company: Join a leading organisation focused on quality excellence.
- Benefits: Competitive salary, career development, and a supportive work environment.
- Other info: Dynamic role with opportunities for travel and professional growth.
- Why this job: Make a real impact on quality standards and regulatory compliance.
- Qualifications: 2 years in GLP, GCP, GMP, or ISO; degree in natural science.
The predicted salary is between 29700 - 36300 £ per year.
Role Overview
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.
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QA Auditor in Macclesfield employer: Synexa Life Sciences (Pty) Ltd.
As a QA Auditor at our organisation, you will be part of a dynamic team dedicated to upholding the highest standards of quality and regulatory compliance. We foster a collaborative work culture that values continuous improvement and offers ample opportunities for professional growth, all within a supportive environment that prioritises employee well-being. Located in a vibrant area, our company provides unique advantages such as flexible working arrangements and access to ongoing training, making it an excellent employer for those seeking meaningful and rewarding careers.
Contact Details:
Synexa Life Sciences (Pty) Ltd. Recruitment Team
