At a Glance
- Tasks: Ensure GMP compliance and foster a proactive quality culture in a dynamic environment.
- Company: Join a leading pharmaceutical company committed to quality and patient safety.
- Benefits: Competitive salary, shift-based work, and opportunities for professional growth.
- Other info: Inclusive workplace welcoming diverse backgrounds and perspectives.
- Why this job: Make a real impact on product quality and patient safety while developing your skills.
- Qualifications: Degree in life sciences or equivalent experience in the pharmaceutical industry.
The predicted salary is between 35000 - 45000 £ per year.
To ensure adherence to GMP standards and procedures through independent oversight of GMP processes; improve the effectiveness of quality by encouraging proactive quality culture and continuous improvement; maintain shift-based presence and be accountable for quality decision-making or escalations; provide first line support to operational areas and maintain inspection-readiness through independent checks.
Responsibilities
- Ensure all GMP processes and operational personnel adhere to current procedures, minimize risk of non‑compliance, and maintain inspection readiness.
- Maintain presence across the area of responsibility and be the first line of contact to support the initial management of quality issues.
- Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real‑time, allowing timely interventions to prevent deviations and defects.
- Provide quality support for site management monitoring audits across GMP areas.
- Ensure adherence to the frequency of oversight mandated in the Quality oversight schedule.
- Check that facilities are maintained in a good state in line with local housekeeping standards; any deviations are escalated with associated actions addressed in a timely manner.
- Role‑model GPS standards, e.g., participating through tiered accountability meetings such as production change‑over meetings.
- Foster a “Quality Starts With Me” culture by coaching employees on following procedures and explaining the impact of non‑compliance on product quality and patient safety.
- Provide out‑of‑hours support for SLE process confirmation of non‑routine or high‑risk activities.
Basic Qualifications
- Degree, HND/HNC or equivalent in a life science, chemistry, microbiology or related subject, or substantial practical laboratory experience.
- Experience in the pharmaceutical industry with excellent working knowledge of QMS / GMP and related manufacturing aspects, or experience in resolving cGMP issues.
- Strong influencing, communication and coaching skills.
- Ability to effectively contribute to departmental project activities.
Preferred Qualifications
- Familiarity with investigation tools and managing CAPA processes.
- Proven experience preparing for audits and inspections.
- Prior experience in on‑site pharmaceutical manufacturing.
Working Pattern
This role is on‑site at Irvine. It is a shift‑based role; exact shift patterns will be discussed during the recruitment process.
Inclusion & Equal Opportunity
We welcome applicants from all backgrounds. GSK is an Equal Opportunity Employer, ensuring that all qualified applicants receive equal consideration for employment without regard to race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law. If you need a reasonable adjustment to the application or interview process, please let us know and we will support you.
Quality Oversight Specialist in Irvine employer: GlaxoSmithKline
At GSK, we pride ourselves on fostering a proactive quality culture that empowers our employees to take ownership of their work and contribute to continuous improvement. As a Quality Oversight Specialist in Irvine, you will benefit from a supportive work environment that prioritises professional growth, offers comprehensive training, and encourages collaboration across teams. Our commitment to diversity and inclusion ensures that every voice is heard, making GSK an exceptional place to build a meaningful career in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Oversight Specialist in Irvine
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to GMP and quality oversight. We recommend doing mock interviews with friends or using online resources to boost your confidence.
✨Tip Number 3
Showcase your passion for quality! During interviews, share examples of how you've contributed to a quality culture in previous roles. This will help you stand out as someone who truly cares about compliance and improvement.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who take that extra step to engage with us directly.
We think you need these skills to ace Quality Oversight Specialist in Irvine
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Oversight Specialist role. Highlight your experience with GMP standards and any relevant qualifications. We want to see how your background aligns 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 oversight and how you can contribute to our proactive quality culture. Keep it engaging and personal – we love a good story!
Showcase Your Skills:Don’t forget to highlight your influencing, communication, and coaching skills in your application. These are key for the role, so give us examples of how you've used them in past experiences. We want to know how you can help foster a 'Quality Starts With Me' culture!
Apply Through Our Website:We encourage you to apply through our website for the best chance of success. It’s straightforward and ensures your application gets to the right people. Plus, you’ll find all the details you need about the role there!
How to prepare for a job interview at GlaxoSmithKline
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practices (GMP) and Quality Management Systems (QMS). Be ready to discuss how you've applied these in your previous roles, as this will show your understanding of the standards expected in the pharmaceutical industry.
✨Showcase Your Coaching Skills
Since the role involves fostering a quality culture, think of examples where you've successfully coached or influenced others. Prepare to share specific instances where your guidance led to improved compliance or quality outcomes.
✨Be Ready for Real-Time Problem Solving
The job requires proactive detection of quality issues. Think about scenarios where you've had to make quick decisions or interventions. Highlight your ability to stay calm under pressure and how you approach problem-solving in a fast-paced environment.
✨Prepare for Audits and Inspections
Since experience with audits is preferred, be prepared to discuss your past experiences in this area. Talk about how you’ve prepared for inspections and any tools or strategies you used to ensure compliance and readiness.