At a Glance
- Tasks: Ensure quality compliance and support continuous improvement in a dynamic QA environment.
- Company: Leading company in the pharmaceutical industry with a focus on quality.
- Benefits: Competitive pay rate, professional development, and a supportive team culture.
- Other info: Opportunity to mentor others and drive continuous improvement initiatives.
- Why this job: Be a key player in maintaining high-quality standards and making a real impact.
- Qualifications: 5-10 years of QA experience and strong knowledge of GMP 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.
Perform Additional Duties As Assigned
Act as a GMP SME enforcing site quality processes.
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 employer: Carbon
As an Associate Principal QA Specialist in Slough, you will join a dynamic team that prioritises quality and continuous improvement, fostering a collaborative work culture. The company offers competitive pay rates, opportunities for professional growth, and a commitment to maintaining high GMP standards, making it an excellent employer for those seeking meaningful and rewarding careers in the quality assurance field.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Principal QA Specialist
✨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 knowledge of GMP compliance and quality processes. We recommend practising common interview questions related to QA and having examples ready that showcase your experience with deviations and CAPAs.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can keep you fresh in the interviewer’s mind and show your enthusiasm for the role. Plus, it’s a great chance to reiterate why you’re the perfect fit.
✨Tip Number 4
Check out our website for the latest job openings! Applying directly through us not only gives you access to exclusive roles but also shows your commitment to joining our team in driving quality and continuous improvement.
We think you need these skills to ace Associate Principal QA Specialist
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 projects you've worked on that align with our needs.
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 your background makes you a perfect fit for our team. Don’t forget to mention your experience with TrackWise records!
Showcase Your Achievements:When detailing your work experience, focus on your achievements rather than just duties. Use metrics where possible to demonstrate how you’ve contributed to quality improvements or compliance in 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 you’re keen to join our team at StudySmarter!
How to prepare for a job interview at Carbon
✨Know Your GMP Inside Out
As an Associate Principal QA Specialist, you'll need to demonstrate a solid understanding of Good Manufacturing Practices (GMP). Brush up on the latest regulations and be ready to discuss how you've applied these in your previous roles. This will show that you're not just familiar with the concepts but can also implement them effectively.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've managed compliance issues or led investigations in the past. Use the STAR method (Situation, Task, Action, Result) to structure your responses. This will help you articulate your experience clearly and highlight your ability to handle critical situations.
✨Familiarise Yourself with TrackWise
Since TrackWise records are crucial for this role, make sure you understand how to navigate and utilise this system. If you have experience with it, be prepared to discuss specific instances where you used TrackWise for deviations, change controls, or CAPAs. If not, do some research to show your willingness to learn.
✨Emphasise Continuous Improvement
This position requires a focus on quality and continuous improvement. Think about initiatives you've led or participated in that improved processes or compliance. Be ready to share these experiences and how they contributed to a culture of quality in your previous workplaces.
