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Validation manager

Wigan
Permanent
Nexus Life Sciences
Validation manager
Posted: 16 February
Offer description

Job Advertisement: 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 com...

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