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.
StudySmarter Expert Advice🤫
We think this is how you could land QA Auditor in Macclesfield
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Synexa Life Sciences looking for candidates who are engaged and informed.
We think you need these skills to ace QA Auditor in Macclesfield
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Synexa Life Sciences. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Synexa Life Sciences
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Synexa Life Sciences’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
