Validation Lead
Posted on Jan 16, 2025 by CV-Library
Galway, Galway County, Ireland
Pharmaceutical
Immediate Start
Annual Salary
Full-Time
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
Reference: 221740306
https://jobs.careeraddict.com/post/98883124
Validation Lead
Posted on Jan 16, 2025 by CV-Library
Galway, Galway County, Ireland
Pharmaceutical
Immediate Start
Annual Salary
Full-Time
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
Reference: 221740306
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