Quality Validation Specialist

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Quality Validation Specialist, Hertfordshire

Client:

Cpl Life Sciences

Location:

Hertfordshire, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Views:

4

Posted:

13.04.2025

Expiry Date:

28.05.2025

Job Description:

Job Title: Quality Validation Specialist

Job Type: Full-time, Permanent Position.

Location: Great London, Hertfordshire area, UK. (On site)

Remuneration: Competitive salary and package.

Cpl Life Sciences is partnering with a growing pharmaceutical company that specializes in Oncology and Neurology. Due to growth within the business, they are looking for a Quality Validation Specialist to join the Quality Operations team.

This role is responsible for ensuring that electronic systems within the Quality Control Laboratory and the Quality Systems operate in accordance with the requirements of the departmental Standard Operating Procedures.

Role Responsibilities:

• Ensure EML’s Electronic TrackWise Quality Management System (QMS) and Quality Control Laboratory systems and software comply with current GMP and Corporate expectations.
• Provide input to the review and writing of any associated quality policies, systems, and procedures as required.
• Support the maintenance and administration of EML’s Electronic TrackWise Quality Management System (QMS) to maintain an effective QMS to meet EML’s requirements.
• Support the management of the administration of QC laboratory system applications providing independence of access for administrator activities.
• Ensure Qualification and Validation of EML equipment, processes, and systems is performed in line with EML procedures, GMP, and GAMP guidelines.
• Ensure the maintenance of EML procedures supporting Qualification and Validation ensuring they are current with updated requirements for Qualification and Validation and cGMP, cGxP expectations.
• Act as a Quality Subject Matter Expert to ensure compliance of Qualification, Validation, and all CSV activities within EML control.

Requirements/Qualifications:

• Ability to understand and analyze user requirements to facilitate changes and system improvements.
• Proficient knowledge of electronic systems, CSV, and GAMP requirements.
• Good understanding of the requirements of data integrity and application to system management.
• Good understanding of Quality Control Systems and analytical software and electronic Quality Systems.
• Ability to interpret complex data and present key findings.
• Ability to describe technical information in easy-to-understand terms.
• Good understanding of GMP Guidelines and Regulations.
• Knowledge of the qualification and validation requirements for equipment and electronic systems.
• Maintain knowledge and understanding of technical advancements in electronic systems.

Please ensure you hold the full right to work in the UK.