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Company:
Sterling Engineering Limited
Category:
Medical
Posted: May 30, 2024
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
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
Read the full job description and apply online on the recuiter's web-site
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