At a Glance
- Tasks: Ensure quality and compliance through audits, CAPA management, and documentation review.
- Company: Join a leading organisation committed to quality excellence and regulatory standards.
- Benefits: Competitive salary, professional development, and opportunities for travel.
- Other info: Collaborative team culture with opportunities for growth and learning.
- Why this job: Make a real impact on quality assurance in a dynamic and supportive environment.
- Qualifications: 2+ years in GLP, GCP, GMP, or ISO; relevant science degree required.
The predicted salary is between 35000 - 45000 £ per year.
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.
- Participate 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.
- 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.
- Approve GMP documentation where applicable.
- Participate in computerized system validation team where applicable.
- Review Standard Operating Procedures for consistency and compliance and maintain 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.
- Work 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.
PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.
QA Auditor in Macclesfield employer: Synexa Life Sciences
As a Quality Assurance 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 professional development, offering ample opportunities for growth in a supportive environment. Located in a vibrant area, our company provides unique advantages such as flexible working arrangements and access to industry-leading training resources, making it an excellent employer for those seeking meaningful and rewarding careers.
