At a Glance
- Tasks: Ensure GMP compliance and improve quality through proactive oversight and support.
- Company: Join a leading pharmaceutical company committed to quality and patient safety.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Shift-based role with a focus on continuous improvement and teamwork.
- Why this job: Make a real impact on product quality and patient safety in a dynamic environment.
- Qualifications: Degree in life sciences or relevant 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. To improve the effectiveness of quality in preventing, identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. To maintain shift based presence and be accountable for key quality decision‑making or quality escalations. To provide first line support to operational areas (for example: rapid response to quality issues, provide guidance and coaching) and maintain inspection‑readiness through independent checks.
Responsibilities
- Ensure that all GMP processes and operational personnel adhere to current local or area specific procedures, minimising risk of non‑compliance and always maintaining inspection readiness.
- Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as the initial impact assessment for deviations.
- Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real‑time, allowing for timely interventions to prevent deviations and defects.
- Provide quality support for site management monitoring audits across GMP areas.
- Ensure adherence to frequency of oversight mandated in the Quality oversight schedule.
- Check that facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated with associated actions addressed within a timely manner.
- Role model the GPS standards for example participating through tiered accountability meetings (for example, production change over meetings).
- Foster a Quality Starts With Me (QSWM) culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non compliance can have on product quality and patient safety.
- Out of hours support for SLE process confirmation of non‑routine or high‑risk activities.
Qualifications
Basic Qualification
- Degree, HND/HNC or equivalent in a life science, chemistry, microbiology or related subject, or substantial practical laboratory experience.
- Experience of the pharmaceutical industry, excellent working knowledge of QMS / GMP and the related manufacturing aspects / experience in resolving cGMP issues.
- Strong influencing, communication and coaching skills.
- Ability to effectively contribute to Department project activities.
Preferred Qualification
- 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. This is a shift‑based role; exact shift patterns will be discussed during the recruitment process.
Inclusion
We welcome applicants from all backgrounds. We aim to create a supportive and inclusive environment where people can learn and do their best work. If you need a reasonable adjustment to the application or interview process, please tell us and we will support you.
Equal Employment Opportunity Statement
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Quality Oversight Specialist in Irvine employer: WISE Campaign
At GSK, we pride ourselves on being an exceptional employer, particularly for the Quality Oversight Specialist role based in Irvine. Our commitment to fostering a proactive quality culture is matched by our dedication to employee growth, offering continuous training and development opportunities in a supportive and inclusive environment. With a focus on maintaining high GMP standards and a strong emphasis on teamwork, we ensure that our employees are empowered to make impactful decisions while contributing to the safety and quality of our products.
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 folks 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 quality oversight. Think about how you’d handle real-life situations and be ready to share your experiences. Confidence is key!
✨Tip Number 3
Show your passion for quality! During interviews, talk about why you care about GMP standards and how you’ve contributed to a proactive quality culture in the past. Let your enthusiasm shine through!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are genuinely interested in joining our team.
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, so we get a sense of who you are.
Showcase Your Skills:Don’t forget to highlight your influencing and coaching skills in your application. We value strong communication, so give us examples of how you've successfully guided others in adhering to quality standards.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets to us quickly and efficiently. Plus, you’ll find all the details you need about the role there!
How to prepare for a job interview at WISE Campaign
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of Good Manufacturing Practices (GMP) and Quality Management Systems (QMS). Be ready to discuss how you've applied these in past roles, as well as any specific experiences with compliance and quality oversight.
✨Showcase Your Coaching Skills
Since the role involves providing guidance and coaching, think of examples where you've successfully influenced others or improved processes. Prepare to share how you foster a proactive quality culture and how you’ve handled quality issues in real-time.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to quality issues or GMP deviations. Practice articulating your thought process for assessing impacts and making decisions, as this will demonstrate your critical thinking and problem-solving skills.
✨Demonstrate Your Audit Preparedness
Highlight any experience you have with preparing for audits and inspections. Be prepared to discuss how you maintain inspection readiness and what steps you take to ensure compliance with local housekeeping standards and oversight schedules.
