At a Glance
- Tasks: Manage Quality Management System processes and support training initiatives.
- Company: Join a dynamic team focused on high-quality standards in the pharmaceutical industry.
- Benefits: Gain opportunities for professional growth and become a qualified auditor.
- Why this job: Be part of a collaborative environment that values quality and innovation.
- Qualifications: Degree in life sciences or equivalent experience; previous quality role in pharmaceuticals required.
- Other info: Exciting chance to engage with global supply chain and participate in audits.
The predicted salary is between 36000 - 60000 £ per year.
Senior Quality Specialist
We are excited to announce an opening for a Senior Quality Specialist role within our dynamic, innovative, and collaborative team. This position is perfect for someone with extensive experience in quality who is eager to contribute to a high-visibility role. The successful candidate will have the opportunity to become a qualified auditor, Responsible Person, and Responsible Person for import if they are not already at this level. Proven experience in quality (especially GDP), strong regulatory knowledge, and excellent communication skills are essential for this role.
About the Role:
As a Senior Quality Specialist, you will be an integral part of the Quality function within the UK & Ireland Commercial affiliate. You will work closely with and support the Senior Quality Manager/Responsible Person to manage all aspects of the Quality Management System (QMS), ensuring that your covered regions are GxP compliant and inspection ready.
If you’re passionate about quality, have a curious and proactive mindset, and are ready to take on new challenges with a high-performing team and department, we would love to hear from you!
Key Responsibilities:
- Take ownership and provide support on QMS processes (Deviations, CAPA & Change Controls) including Root Cause Analysis, Risk Assessment, Action completion, and timely closure of records.
- Act as a Training Specialist – accountable for the UKIE Training Matrix, manage training within iLearn, conduct monthly Quality Inductions, and provide general business support.
- Act as an SME for Quality Risk Management – chair Risk Management Committee Meetings, ensure all identified GxP risks are captured and progressed, complete trending, reporting, and measure process effectiveness.
- Manage GxP Change Controls including oversight, progression of records, trending, reporting, and measuring process effectiveness.
- Log and manage Temperature Excursions.
- Manage controlled documentation, including the completion of gap analyses vs. global document updates.
- Lead the completion of Product Quality Review.
- Responsible for the management of the Quality function’s section of the RQ SharePoint.
- Engage with local and global supply chain colleagues to maintain awareness of planned shipments and product types.
- Complete Internal and External Vendor Audits and provide support during local and global inspections and audits.
- Complete activities conducted by the RQ Officer in times of absence, including:
- Administrative activities associated with the electronic document system (Easidoc).
- Creation & Allocation of training in the electronic training system (iLearn).
- Complete delegated activities for the Responsible Person (UKIE) in times of absence.
Essential Requirements:
- Educated to Degree level (life sciences) or equivalent experience.
- Previous experience within a Quality role.
- Previous experience within the pharmaceutical industry.
- Detailed knowledge of EU Good Distribution Practice and MHRA/HPRA requirements.
- Experience participating in both internal GxP audits and regulatory inspections.
- Knowledge and training within GxP.
- Advanced knowledge of Microsoft Office.
- Excellent verbal, written, analytical, and interpersonal skills.
- Self-motivated, organized, and able to problem-solve.
This is an exciting opportunity to be part of an innovative and collaborative team dedicated to ensuring the highest quality standards in the pharmaceutical industry. If you meet the qualifications and are eager to take on a critical role in quality management, we encourage you to apply!
Senior Quality Specialist employer: Meet
Contact Detail:
Meet Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Specialist
✨Tip Number 1
Familiarize yourself with the latest EU Good Distribution Practice (GDP) guidelines and MHRA/HPRA requirements. This knowledge will not only help you in interviews but also demonstrate your commitment to quality standards in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the quality management field, especially those who have experience in GxP audits and regulatory inspections. Engaging with industry peers can provide valuable insights and potentially lead to referrals for the Senior Quality Specialist role.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed QMS processes like Deviations, CAPA, and Change Controls in your previous roles. Highlighting your hands-on experience will set you apart as a strong candidate.
✨Tip Number 4
Showcase your communication skills by practicing how you would explain complex quality concepts to non-experts. Being able to convey information clearly is crucial for a Senior Quality Specialist, especially when conducting training sessions.
We think you need these skills to ace Senior Quality Specialist
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Senior Quality Specialist position. Make sure you understand the key responsibilities and essential requirements, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your previous experience in quality roles, particularly within the pharmaceutical industry. Mention specific examples of your work with QMS processes, GxP compliance, and any relevant audits you've participated in.
Showcase Your Skills: Make sure to highlight your strong regulatory knowledge and excellent communication skills. Provide examples of how you've effectively communicated complex information or led training sessions, as these are crucial for the role.
Tailor Your Application: Customize your cover letter to reflect your passion for quality and your proactive mindset. Address how you can contribute to the team and support the Senior Quality Manager, making it clear why you're a great fit for this high-visibility role.
How to prepare for a job interview at Meet
✨Showcase Your Quality Experience
Be prepared to discuss your previous roles in quality management, especially any experience related to GDP and GxP compliance. Highlight specific examples where you successfully managed QMS processes or conducted audits.
✨Demonstrate Regulatory Knowledge
Familiarize yourself with EU Good Distribution Practice and MHRA/HPRA requirements. During the interview, confidently discuss how your knowledge aligns with the company's needs and how you can contribute to maintaining compliance.
✨Communicate Effectively
Excellent communication skills are essential for this role. Practice articulating your thoughts clearly and concisely, and be ready to explain complex quality concepts in a way that is easy to understand.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities and decision-making skills. Prepare to discuss how you would handle specific quality-related scenarios, such as managing deviations or conducting root cause analysis.