At a Glance
- Tasks: Lead validation and qualification activities to ensure compliance with industry standards.
- Company: Join a leading company in the pharmaceutical and life sciences sector.
- Benefits: Permanent position with opportunities for professional growth and development.
- Other info: Collaborative culture focused on continuous improvement and compliance.
- Why this job: Make a real impact on quality assurance in a dynamic environment.
- Qualifications: Degree in Science, Engineering, or Pharmacy with GMP experience preferred.
The predicted salary is between 50000 - 65000 £ per year.
A key opportunity has arisen in our Quality team, we are looking for a Validation and Qualification Manager. The role acts as the technical subject matter expert for validation and qualification activities associated with facilities, utilities, manufacturing equipment, processes, cleaning systems and analytical methods.
The Validation Lead ensures that all validation activities are conducted in accordance with GMP, MHRA requirements, EU GMP Annex 15, ICH guidance and internal quality standards, maintaining the validated state throughout the lifecycle of GMP systems and processes. The role also provides technical leadership during regulatory inspections, customer audits and certification assessments.
Key Responsibilities- Accountable for establishing, maintaining and continuously improving the site Validation Master Plan and associated validation framework across both the Sodium Bicarbonate and British Salt operations.
- Responsible for ensuring validation standards, procedures, templates and governance systems remain inspection-ready and support a compliant, risk-based approach to validation across the business.
- Responsible for ensuring that facilities, utilities and equipment remain in a qualified state throughout their operational lifecycle. This includes oversight and approval of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities, ensuring all qualification work is appropriately documented, scientifically justified and compliant with regulatory requirements.
- Provides technical leadership and coaching across the organisation to promote a strong validation and GMP compliance culture working with internal stakeholders to improve validation practices, implement risk-based approaches and identify opportunities to strengthen compliance and operational effectiveness.
We want someone who can hit the ground running with our Validation programme across TCE. The ideal candidate will be a proven Validation and Qualification professional preferably with a degree in Science, Engineering, Pharmacy or related discipline and will have the following experience:
- GMP experience within pharmaceutical, API, chemical or life sciences manufacturing would be great with a strong understanding of Annex 15, ICH Q7 to Q10.
- Experienced in leading DQ, IQ, OQ, PQ, process and cleaning validation.
- Supported regulatory inspections as well as MHRA inspections.
- Audit qualifications would be advantageous.
- Proven experience of managing stakeholders through a validation programme with strong influencing skills to create a proactive approach.
- Worked collaboratively in previous roles with Production, Engineering and Quality functions to support process improvements while maintaining regulatory compliance.
Validation and Qualification Manager in Aylesbury employer: Morson Edge
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StudySmarter Expert Advice🤫
We think this is how you could land Validation and Qualification Manager in Aylesbury
✨Unlock Networking Opportunities
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Morson Edge.
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Morson Edge. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Morson Edge is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Validation and Qualification Manager in Aylesbury
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Morson Edge!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Morson Edge that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Morson Edge!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Morson Edge, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Morson Edge
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Morson Edge that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Morson Edge’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
