Quality Validation Specialist
We are recruiting for a Quality Validation Specialist to join our team at CK Group, a global pharmaceutical company based in Hatfield, Hertfordshire.
Role Overview
This role is responsible for ensuring that electronic systems within the Quality Control Laboratory and Quality Systems operate in accordance with departmental Standard Operating Procedures.
* Provide input to review and writing of quality policies, systems, and procedures as required, prepare and update SOPs and training materials for system administration activities, Qualification, and Validation activities.
* Support maintenance and administration of Electronic QMS.
* Support effective management 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.
* Ensure 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 set up and change management of system data and ensure continuous system availability and functionality.
* Support management of relationships with external system providers for technical and helpdesk support and coordinate and lead system updates and upgrades with system providers.
* Manage provision of training on requirements for CSV and IT qualification and validation.
* Support change control process to ensure requirements of qualification and validation are included.
Your Background
To be successful in this role, you will have:
* 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 ability to understand and analyse user requirements to facilitate changes and system improvements.
* Good understanding of 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 qualification and validation requirements for equipment and electronic systems.
* Excellent verbal and written communication skills.
About Us
CK Group is a global pharmaceutical company based in Hatfield, Hertfordshire. We offer a range of career opportunities across various fields.
How to Apply
Please note that it is essential to hold entitlement to work in the UK to apply for this role. Please quote job reference 128633 in all correspondence.