Validation Lead

6 days ago


Galway, Ireland Sterling Engineering Limited Full time

Validation LeadRole Overview: * A fantastic company who are committed to maintaining the highest standards of pharmaceutical validation to ensure the safety and efficacy of our products. * As a Validation Lead, you will play a crucial role in overseeing validation activities across our operations, collaborating with various departments to uphold regulatory compliance and quality standards.Responsibilities include: * Contribute to the preparation and review of the Validation Master Plan for process and cleaning validation. * Manage validation requirements for the Company and third-party suppliers and Contract Manufacturing Organizations (CMOs). * Oversee the preparation, review, and issuance of validation protocols and reports, encompassing equipment, cleaning, process, and computer system validation. * Maintain and take ownership of the cleaning validation strategy at Chanelle, ensuring compliance with regulatory authorities in the EU. * Establish, implement, and direct validation and revalidation activities. * Liaise with contract manufacturing customers to obtain approval for protocols and reports when necessary.Competencies: * In-depth knowledge of process and cleaning validation. * Ability to conduct internal and external audits effectively. * Minimum Bachelor of Science or Engineering degree. * Health & Safety requirements, including Manual Handling Training. * Ability to ensure compliance with safety regulations and maintain a safe work environment. * Familiarity with HPRA and USFDA regulations and experience in regulatory compliance. * Minimum of 2 years of relevant experience in a similar position



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