Validation and Qualification Manager

Tata Chemicals Europe; Northwich; On-site; GBP 55,000 - 65,000; Full time

Benefits offered by this job

37 days holidays per year, inclusive

Roll over of up to 5 days

Volunteer day each year

37.5 hours per week

Pension up to 9%

Life insurance

Private healthcare

Job summary

Tata Chemicals Europe in Northwich is seeking a Validation and Qualification Manager to lead the site validation lifecycle across our Sodium Bicarbonate and Medi-Salt operations.

You will drive DQ/IQ/OQ/PQ activities, ensure compliance with GMP and MHRA expectations, and provide leadership during regulatory inspections and internal audits. A strong background in QA/validation within pharma or chemical industries is essential.

Qualifications

• GMP experience within pharmaceutical, API, chemical or life sciences manufacturing with knowledge of Annex 15 and ICH Q7–Q10.
• Experience leading DQ, IQ, OQ, PQ, process and cleaning validation.
• Supported regulatory inspections including MHRA inspections.

Responsibilities

• Establish, maintain and improve the site Validation Master Plan and validation framework across Sodium Bicarbonate and Medi-Salt operations.
• Ensure validation standards, procedures, templates and governance are inspection-ready and align with regulatory requirements.
• Oversee Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities and document accordingly.
• Provide technical leadership to promote validation and GMP compliance culture and support audits and inspections.

Skills

GMP experience

Annex 15 / ICH Q7–Q10

DQ/IQ/OQ/PQ leadership

Regulatory inspections

Audit qualifications

Stakeholder management

Cross-functional collaboration

Job description

Application Deadline: 21 August 2026

Department: Quality

Location: Natrium House - Northwich, Cheshire

Compensation: £55,000 - £65,000 / year

Validation and Qualification Manager

Shape the Future of Pharmaceutical Manufacturing with Tata Chemicals Europe

Built on over 100 years of scientific expertise and driven by exceptional people, Tata Chemicals Europe is a business with a proud heritage and an exciting future. Across our Cheshire sites, our colleagues are helping us deliver premium products, outstanding customer service, and a positive impact on our communities and environment. Now, we're entering an exciting new chapter.

Be Part of Something Ground-Breaking

We've launched Medi-Salt, the UK's first dedicated pharmaceutical-grade salt manufacturing facility. Producing high-purity salt for use as both an Active Pharmaceutical Ingredient (API) and pharmaceutical excipient, Medi-Salt is setting new standards in quality, compliance and innovation.

A key opportunity has arisen in our Quality team, we are looking for a Validation and Qualification Manager.

The successful candidate will be responsible for establishing, maintaining and continuously improving the validation lifecycle programme across the Tata Chemicals Europe Sodium Bicarbonate and British Salt Medi-Salt operations.

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

• 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 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.

Perks

• 37 days holidays per year, inclusive of Bank Holidays
• Roll over of up to 5 days and salary sacrifice holiday purchase scheme
• An additional paid day off each year to volunteer for a good cause in the local community
• 37.5 hours per week, Monday to Friday
• Excellent contributory Pension scheme up to 9% company contribution
• Life insurance
• Private Healthcare