Validation Lead

Galway
3 weeks ago
Applications closed

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Role 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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