Your key responsibilities will include:

• Ensuring batch release and associated activities are conducted in line with internal procedures, cGMP and the LEO Quality Management System.
• Reviewing, approving and authorising quality documentation, including batch records, worksheets, deviations, CAPAs, change controls, validation documentation and laboratory investigations.
• Supporting root cause analysis and CAPA definition in collaboration with relevant stakeholders.
• Releasing or rejecting APIs and intermediates in accordance with applicable requirements.
• Driving quality improvements, harmonisation and simplification of procedures across API Quality and Global Quality.

You will also compile quality metrics, support supplier audit information requests, contribute to Annual Product Quality Reviews, provide GMP induction training and work with systems such as Veeva Vault, PowerBI, MyDoc and SAP.

A key part of your success will be your ability to release batches within the allowed lead time and approve Quality records within the lead times assigned to the Quality Release and Support department, communicate investigation outcomes, quality risks and required actions clearly and confidently across functions.

Your Qualifications

To succeed in this role, you will bring a strong quality background, solid GMP knowledge and hands-on experience in a regulated pharmaceutical environment. Experience with laboratory investigations, deviation management and cross-functional quality communication will be especially important.

We are looking for someone with:

• A third-level qualification in a relevant scientific discipline, supported by relevant pharmaceutical industry experience.
• Deep knowledge of cGMP, including EU GMP Volume 4 Parts I and II, relevant annexes, and 21 CFR Parts 210, 211 and Part 11.
• Experience with laboratory investigations, deviation management, and Change Controls, SOPs, investigations and validation documentation.
• Practical understanding of API manufacturing, batch release, laboratory investigations and quality systems.
• Experience using quality and business systems such as Veeva Vault, PowerBI, MyDoc and SAP would be an advantage.

As a person, you bring an inherent quality mindset, attention to detail and a strong sense of accountability. You are comfortable asking the right questions, challenging constructively and communicating complex quality matters in a clear, confident and collaborative way.

Your key responsibilities will include:

• Ensuring batch release and associated activities are conducted in line with internal procedures, cGMP and the LEO Quality Management System.
• Reviewing, approving and authorising quality documentation, including batch records, worksheets, deviations, CAPAs, change controls, validation documentation and laboratory investigations.
• Supporting root cause analysis and CAPA definition in collaboration with relevant stakeholders.
• Releasing or rejecting APIs and intermediates in accordance with applicable requirements.
• Driving quality improvements, harmonisation and simplification of procedures across API Quality and Global Quality.

You will also compile quality metrics, support supplier audit information requests, contribute to Annual Product Quality Reviews, provide GMP induction training and work with systems such as Veeva Vault, PowerBI, MyDoc and SAP.

A key part of your success will be your ability to release batches within the allowed lead time and approve Quality records within the lead times assigned to the Quality Release and Support department, communicate investigation outcomes, quality risks and required actions clearly and confidently across functions.

Your Qualifications

To succeed in this role, you will bring a strong quality background, solid GMP knowledge and hands-on experience in a regulated pharmaceutical environment. Experience with laboratory investigations, deviation management and cross-functional quality communication will be especially important.

We are looking for someone with:

• A third-level qualification in a relevant scientific discipline, supported by relevant pharmaceutical industry experience.
• Deep knowledge of cGMP, including EU GMP Volume 4 Parts I and II, relevant annexes, and 21 CFR Parts 210, 211 and Part 11.
• Experience with laboratory investigations, deviation management, and Change Controls, SOPs, investigations and validation documentation.
• Practical understanding of API manufacturing, batch release, laboratory investigations and quality systems.
• Experience using quality and business systems such as Veeva Vault, PowerBI, MyDoc and SAP would be an advantage.

As a person, you bring an inherent quality mindset, attention to detail and a strong sense of accountability. You are comfortable asking the right questions, challenging constructively and communicating complex quality matters in a clear, confident and collaborative way.

Your New Team