Quality Validation Specialist

TN United Kingdom; Hatfield; On-site; GBP 40,000 - 65,000; Full time

Job summary

Join a well-established global pharmaceutical company as a Quality Validation Specialist in Hatfield. This role ensures that electronic systems within the Quality Control Laboratory comply with departmental Standard Operating Procedures. You'll be responsible for maintaining the Electronic Quality Management System, supporting validation activities, and managing relationships with external system providers. If you have a background in scientific education and experience in Electronic Quality Systems, this opportunity offers a chance to make a significant impact in a dynamic environment focused on quality and compliance.

Qualifications

• Degree level education in a scientific field with experience in Electronic Quality Systems.
• Proficient in CSV and GAMP requirements with strong analytical skills.

Responsibilities

• Ensure compliance of Electronic QMS and QC Laboratory systems with GMP.
• Support the management of relationships with external system providers.

Skills

Electronic Quality Systems

CSV (Computer System Validation)

GAMP (Good Automated Manufacturing Practice)

Data Integrity

Quality Control Systems

Analytical Software

GMP Guidelines

Communication Skills

Education

Degree in a Scientific Field

Job description

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CK Group are recruiting for a Quality Validation Specialist to join a well-established and successful global pharmaceutical company, based in Hatfield, Hertfordshire, on a permanent basis.

Role:

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.

Key duties will include :

1. Ensure the Electronic Quality Management System (QMS) and Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage, and distribution of marketed drug products comply with current GMP and company expectations.
2. Provide input to the review and writing of any associated quality policies, systems, and procedures as required, and prepare and update SOPs and training materials for system administration activities, Qualification, and Validation activities.
3. Support the maintenance and administration of the Electronic QMS.
4. Support the effective management of the administration of QC laboratory system applications, providing independence of access for administrator activities.
5. Ensure Qualification and Validation of equipment, processes, systems are performed in line with procedures, GMP, and GAMP guidelines, as required.
6. Ensure the maintenance of procedures supporting Qualification and Validation, and review and approve Qualification and Validation documentation.
7. Ensure user access to systems is maintained per procedures and support the setup and change management of system data, ensuring continuous system availability and functionality.
8. Support the management of relationships with external system providers for technical and helpdesk support, and coordinate system updates and upgrades.
9. Manage the provision of training on CSV and IT qualification and validation requirements.
10. Support the change control process to include qualification and validation requirements.

Your Background:

• Educated to degree level or above in a scientific or related field with significant experience in a pharmaceutical industry role focused on Electronic Quality Systems.
• Proficient knowledge of electronic systems, CSV, and GAMP requirements, with the ability to understand and analyze user requirements for system improvements.
• Good understanding of data integrity requirements and their application to system management.
• Good understanding of Quality Control Systems, analytical software, and electronic Quality Systems.
• Good understanding of GMP Guidelines and Regulations.
• Knowledge of qualification and validation requirements for equipment and electronic systems.
• Excellent verbal and written communication skills.