Validation Manager

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Validation Manager

Overview

Currently seeking an experienced Validation Manager to join a leading pharmaceutical manufacturing facility. The validation manager will lead a team to plan and execute validation activities in alignment with the Validation Master Plan.

Responsibilities

* Create/review/execute validation protocols and reports.

* Address ICH Q3D Elemental Impurities and Permitted Daily Exposure (PDE) requirements.

* Manage change controls for validated systems to maintain compliance.

* Perform risk assessments and implement risk-based approaches.

* Resolve process deviations and implement CAPA.

* Oversee cleaning validation, including hold time studies.

* Conduct process validation for mixing, filling, revalidation, and new product methodologies.

* Support validation activities for regulatory submissions.

* Provide validation input for NPD/NPI projects.

* Prepare for regulatory audits and ensure compliance with GMP.

* Collaborate with teams on continuous improvement initiatives.

Qualifications

* Industry validation experience in pharmaceutical manufacturing.

* Knowledge of validation processes and ICH Q3D/PDE requirements.

* Degree in Life Sciences or Engineering preferred.

* Strong problem-solving and project management skills.

* Excellent communication and interpersonal abilities.

* Commitment to health, safety, and GMP compliance.

Benefits

* Salary: £40,000 - £50,000.

* Career development in a leading pharmaceutical company.

* Collaborative, supportive work environment.

* Opportunity to contribute to public health improvements.

If you’re an experienced validation manager based in the North West, get in touch