Quality Validation Specialist

CK Group; Hatfield; On-site; GBP 30,000 - 50,000; Full time

Job description

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:

• 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.
• 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.
• Support the maintenance and administration of the Electronic QMS.
• Support the effective management of the administration of QC laboratory system applications providing independence of access for administrator activities.
• Ensure Qualification and Validation of equipment, processes, systems is/are performed in line with procedures, GMP and GAMP guidelines for process, equipment and electronic systems, as and when required.
• Ensure the maintenance of procedures supporting Qualification and Validation and review and approve Qualification and Validation documentation.
• Ensure user access to systems is maintained in line with procedures and support is provided to facilitate the set up and change management of system data and ensure continuous system availability and functionality.
• Support the Management of the relationships with external system providers for technical and helpdesk support and coordinate and lead system updates and upgrades with the system providers.
• Manage the provision of training on the requirements for CSV and IT qualification and validation.
• Support the change control process to ensure the requirements of qualification and validation are included.

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 and the ability to understand and analyse user requirements to facilitate changes and system improvements.
• 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.
• Good understanding of GMP Guidelines and Regulations.
• Knowledge of the qualification and validation requirements for equipment and electronic systems.
• Excellent verbal and written communication skills.

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 128 633 in all correspondence.