Validation and Qualification Manager
$55,000–$65,000 year
On-siteNorthwich, England, United Kingdom
Job Summary
Establish and continuously improve the site Validation Master Plan and associated framework across Sodium Bicarbonate and British Salt operations. Ensure all validation activities adhere to GMP, MHRA, EU GMP Annex 15, and ICH guidance while maintaining inspection readiness. Oversee Design, Installation, Operational, and Performance Qualification for facilities, utilities, equipment, and analytical methods to ensure they remain in a qualified state. Provide technical leadership during regulatory and customer audits, coaching internal stakeholders to strengthen compliance culture and operational effectiveness. Manage the validation lifecycle with a risk-based approach across both operations.
Required Qualifications
- proven Validation and Qualification professional
- degree in Science, Engineering, Pharmacy or related discipline
- GMP experience within pharmaceutical, API, chemical or life sciences manufacturing
- 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
- Proven experience of managing stakeholders thorough 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
Desired Qualifications
- GMP experience within pharmaceutical, API, chemical or life sciences manufacturing would be great with a strong understanding of Annex 15, ICH Q7 to Q10
- Audit qualifications would be advantageous
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