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.
* 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.
* 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
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