At a Glance
- Tasks: Lead validation and qualification activities for manufacturing processes and equipment.
- Company: Join a leading company in the pharmaceutical and life sciences sector.
- Benefits: Permanent position with competitive salary and opportunities for professional growth.
- Other info: Collaborative culture with strong focus on continuous improvement and compliance.
- Why this job: Make a real impact on quality assurance and compliance in a dynamic environment.
- Qualifications: Degree in Science, Engineering, or Pharmacy; GMP experience preferred.
The predicted salary is between 60000 - 75000 £ 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.
Skills, Knowledge and Expertise
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 employer: Morson Edge
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