At a Glance
- Tasks: Lead QC lab equipment lifecycle and ensure compliance in a dynamic pharmaceutical environment.
- Company: Join a leading pharmaceutical company focused on quality and innovation.
- Benefits: Competitive salary, career growth, and a chance to make a real impact.
- Other info: Hands-on role with leadership opportunities and a focus on compliance.
- Why this job: Be at the forefront of quality control and systems validation in a vital industry.
- Qualifications: Degree in Chemistry or related field with HPLC experience required.
We are seeking an experienced QC Validation & Systems Lead to take ownership of QC laboratory equipment lifecycles and computerized systems within a GMP-regulated environment. This senior, hands-on role blends equipment validation, CSV, data integrity, and team leadership, ensuring QC operations remain compliant, efficient and inspection-ready at all times.
Key Responsibilities
- Own the full lifecycle of QC laboratory equipment, including procurement, qualification, maintenance, change control, and retirement.
- Lead equipment validation activities (IQ/OQ/PQ) and manage site calibration programmes, including oversight of external service providers.
- Manage QC equipment and validation status using electronic systems (e.g. LIMS), ensuring GMP compliance and inspection readiness.
- Lead Computer System Validation (CSV) and administration for QC systems such as Empower and LabX, ensuring data integrity and regulatory compliance.
- Author and approve validation and GMP documentation, and lead deviation investigations, impact assessments, and CAPA related to equipment and systems.
- Provide technical leadership and line management to a small QC systems team and act as SME during internal and regulatory audits.
The QC Validation Lead must have:
- Degree (BSc or equivalent) in Chemistry or a relevant scientific discipline, with essential HPLC experience in a pharmaceutical or GMP-regulated laboratory.
- Strong working knowledge of GMP, Health & Safety and COSHH requirements.
- Proven experience in laboratory equipment qualification, validation, calibration, and troubleshooting especially for HPLC systems.
- Hands-on experience with QC computerized systems (e.g. Empower, LabX), including CSV and a solid understanding of Data Integrity principles.
- Confidence representing QC during audits and inspections, with previous supervisory or team leadership experience preferred.
Please note: my client is unable to offer sponsorship on this role.
QC Validation & Systems Lead employer: Nexus Life Sciences
Contact Detail:
Nexus Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QC Validation & Systems Lead
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in QC or validation. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge. Make sure you can confidently discuss HPLC systems and GMP compliance. We want you to shine when they ask about your hands-on experience!
✨Tip Number 3
Showcase your leadership skills! Be ready to share examples of how you've led teams or projects in the past. This role is all about taking ownership, so let them know you're the right person for the job.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace QC Validation & Systems Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QC Validation & Systems Lead role. Highlight your experience with HPLC systems and GMP compliance, as these are key for us. Use specific examples that showcase your skills in equipment validation and team leadership.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for our team. Mention your hands-on experience with QC computerized systems and how you can contribute to maintaining compliance and efficiency in our lab.
Showcase Your Technical Skills: Don’t forget to highlight your technical expertise in your application. We want to see your knowledge of CSV and data integrity principles, so be sure to include any relevant projects or achievements that demonstrate your capabilities.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss out on any important updates. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Nexus Life Sciences
✨Know Your Stuff
Make sure you brush up on your knowledge of QC laboratory equipment and GMP regulations. Be ready to discuss your hands-on experience with HPLC systems and how you've managed equipment lifecycles in the past.
✨Showcase Your Leadership Skills
Since this role involves leading a small team, be prepared to share examples of your previous supervisory experiences. Highlight how you've motivated your team and handled challenges in a QC environment.
✨Be Audit-Ready
Familiarise yourself with the audit process and be ready to discuss how you've represented QC during inspections. Share specific instances where you ensured compliance and data integrity in your previous roles.
✨Prepare for Technical Questions
Expect technical questions related to equipment validation and Computer System Validation (CSV). Brush up on your knowledge of electronic systems like Empower and LabX, and be ready to explain how you've used them to maintain compliance.