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- Tasks: Ensure quality compliance and support continuous improvement in a dynamic QA environment.
- Company: Join a leading company focused on quality and innovation in the pharmaceutical industry.
- Benefits: Competitive pay, professional development opportunities, and a supportive team culture.
- Other info: Opportunity to mentor others and lead quality initiatives in a collaborative setting.
- Why this job: Make a real impact by ensuring compliance and driving quality improvements.
- Qualifications: 5-10 years of QA experience with strong knowledge of GMP and quality processes.
The predicted salary is between 60000 - 65000 £ per year.
Location: Slough
Contract Length: 12 months
Working Hours: 37.5 hours/week
Pay Rate: up to £32.76 p/h DOE
About the Role
Provide QA review and oversight for various studies and activities. Support a culture of quality and continuous improvement within QC and Development Services. Support Operations to ensure ongoing compliance with GMP. Manage and support GMP issues through QMS processes, site governance and senior QA leadership. Act as a GMP Subject Matter Expert (SME) by implementing, managing and enforcing quality processes on site. Support senior QA leadership in driving continuous improvement and ensuring processes are 'fit for purpose'. Ensure compliance with GMP requirements within Development Services. Maintain compliance with Regulatory Authority expectations, Global Quality Standards and customer requirements.
Key Responsibilities
- Provide shoulder-to-shoulder review, approval and support for deviations, CAPAs, change controls, investigations and OOS records.
- Review QA activities for MSAT studies, pilot studies, and Development Services.
- Review QC activities including method validation, reference standards and stability studies.
- Manage and escalate critical compliance issues through the QMS.
- Conduct audit trail reviews.
- Perform area walkthroughs to identify and resolve non-compliance.
- Audit raw data, protocols and validation reports for GMP compliance.
- Maintain and promote audit readiness.
- Ensure protocols and validation reports are approved according to project schedules.
- Lead process audits and support GMP audit activities.
- Identify and participate in continuous improvement initiatives.
- Support quality governance via Local Quality Councils and project meetings.
- Provide QA SME support for Operations, QC, MSAT and Development Services.
- Mentor and coach business partners in GMP practices.
- Advise scientists on documentation and follow-up expectations.
- Provide out-of-hours QA support where required.
- Act as a GMP SME enforcing site quality processes.
- Perform additional duties as assigned.
Skills/Education
Education/Degree: Field of Study Scientific Work Experience: Quality (QA or QC) Level - Advanced - 5-10 years
Top three must have experience:
- QA Manufacturing experience
- TrackWise records experience (Deviations, Change controls, CAPA's, investigations)
- OOS investigations
Nice to have experience:
- Audit experience
Associate Principal QA Specialist in Slough employer: Carbon 60
Contact Detail:
Carbon 60 Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Principal QA Specialist in Slough
✨Tip Number 1
Network like a pro! Reach out to your connections in the QA field, especially those who work in GMP environments. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your GMP knowledge and recent trends in QA. We recommend practising common interview questions and having examples ready that showcase your experience with deviations and CAPAs.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds!
✨Tip Number 4
Apply through our website for the best chance at landing that Associate Principal QA Specialist role. We’re always on the lookout for passionate candidates who are ready to support a culture of quality and continuous improvement!
We think you need these skills to ace Associate Principal QA Specialist in Slough
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Associate Principal QA Specialist role. Highlight your relevant QA experience, especially in GMP compliance and any specific tools like TrackWise. We want to see how your background fits with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our culture of continuous improvement. Keep it concise but impactful – we love a good story!
Showcase Your Achievements: When detailing your work experience, focus on your achievements rather than just duties. Did you lead a successful audit or improve a process? We want to know how you've made a difference in your previous roles!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen to join the StudySmarter team!
How to prepare for a job interview at Carbon 60
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practices (GMP) before the interview. Be ready to discuss how you've implemented and enforced quality processes in your previous roles. This will show that you're not just familiar with the concepts, but that you can apply them effectively.
✨Showcase Your QA Experience
Prepare specific examples from your past work where you've managed QA activities, especially around deviations, CAPAs, and investigations. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewer to see your impact.
✨Demonstrate Continuous Improvement Mindset
Be ready to talk about how you've contributed to continuous improvement initiatives in your previous positions. Highlight any specific projects or changes you led that enhanced compliance or efficiency, as this aligns perfectly with the role's focus on quality culture.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to quality governance and how they handle compliance issues. This not only shows your interest in the role but also gives you a chance to assess if their values align with yours.