Pharma Validation & Qualification Leader

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

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.