Validation Lead

Posted 02/07/2024 by Sterling Engineering Limited

Location:
Galway, County Galway

Validation Lead

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.
Type:
Permanent
Start Date:
Immediate
Contract Length:
Ongoing
Job Reference:
KNYL 1487
Job ID:
221740306
Applications:
Less than 10

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