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Quality Control Validation Manager
Quality Control Validation Manager
Quality Control Validation Manager
Posted 8 days ago
- London, Greater London
- Any
- External
Calling all QC Validation professionals, this is a unique opportunity to make real change within the Biotech field.
I'm working with a client in London UK who is a leading Biotech company. You will be closely working with a wider team to make real change within organisations within the biotech field. All while representing company standards like innovation, quality and excellence
.
Key Responsibilities:
Lead the development and validation of both established and innovative analytical test methods for current and newly developed gene therapy products.
Act as the subject matter expert for lifecycle management of analytical assays, equipment, and materials, including in-process samples and finished products.
Develop and manage qualification/validation projects, ensuring all supporting documentation aligns with compliance requirements.
Ensure all methods are validated and executed in QC GMP laboratories, adhering to regulatory standards and data integrity requirements.
Support the validation of methods for raw material testing and sampling booth activities.
Manage the implementation of test methods, ensuring timelines are met to facilitate the seamless launch of new products.
Oversee external testing activities to ensure compliance with GMP standards.
Maintain effective communication with key stakeholders, ensuring the timely update of information folders with the latest versions and relevant communications.
Facilitate the development and delivery of training on new technologies or methodologies introduced to the facility.
Conduct routine assessments of analytical methods to ensure their proper application and performance.
Provide support for employee training as needed.
Job Description:
Support the maintenance of the Quality Management System, ensuring document control and the integrity of all generated data.
Assist with managerial requests and handle ad-hoc tasks as required.
Ensure compliance with Quality, Safety, and Environmental standards and procedures within the designated area.
Follow procedures, including Health and Safety protocols and GMP regulations.
Track, monitor, and meet personal KPIs, objectives, and targets within specified timelines.
Ensure both your work and the team's adhere to GMP, Data Integrity, and Good Documentation Practices (GDP), following applicable procedures.
Ensure timely and compliant completion of all GMP documentation (e.g., Issues, CAPAs, Change Controls, BMRs, and audit/inspection actions) in your area of responsibility, ensuring they are right-first-time (RFT).
Requirements:
Degree in Human Health or Sciences equivalent relevant work experience
Experience in a validation role in the Biotech or Pharma industry
Previously managed a team
Experience working on several projects
5+ experience working in a GMP environment
Willing to occasionally travel to Ireland
I'm working with a client in London UK who is a leading Biotech company. You will be closely working with a wider team to make real change within organisations within the biotech field. All while representing company standards like innovation, quality and excellence
.
Key Responsibilities:
Lead the development and validation of both established and innovative analytical test methods for current and newly developed gene therapy products.
Act as the subject matter expert for lifecycle management of analytical assays, equipment, and materials, including in-process samples and finished products.
Develop and manage qualification/validation projects, ensuring all supporting documentation aligns with compliance requirements.
Ensure all methods are validated and executed in QC GMP laboratories, adhering to regulatory standards and data integrity requirements.
Support the validation of methods for raw material testing and sampling booth activities.
Manage the implementation of test methods, ensuring timelines are met to facilitate the seamless launch of new products.
Oversee external testing activities to ensure compliance with GMP standards.
Maintain effective communication with key stakeholders, ensuring the timely update of information folders with the latest versions and relevant communications.
Facilitate the development and delivery of training on new technologies or methodologies introduced to the facility.
Conduct routine assessments of analytical methods to ensure their proper application and performance.
Provide support for employee training as needed.
Job Description:
Support the maintenance of the Quality Management System, ensuring document control and the integrity of all generated data.
Assist with managerial requests and handle ad-hoc tasks as required.
Ensure compliance with Quality, Safety, and Environmental standards and procedures within the designated area.
Follow procedures, including Health and Safety protocols and GMP regulations.
Track, monitor, and meet personal KPIs, objectives, and targets within specified timelines.
Ensure both your work and the team's adhere to GMP, Data Integrity, and Good Documentation Practices (GDP), following applicable procedures.
Ensure timely and compliant completion of all GMP documentation (e.g., Issues, CAPAs, Change Controls, BMRs, and audit/inspection actions) in your area of responsibility, ensuring they are right-first-time (RFT).
Requirements:
Degree in Human Health or Sciences equivalent relevant work experience
Experience in a validation role in the Biotech or Pharma industry
Previously managed a team
Experience working on several projects
5+ experience working in a GMP environment
Willing to occasionally travel to Ireland