Quality Systems Associate - Qualification and Administration

CK Group are recruiting for a Quality Systems Associate - Qualification and Administration to join a company in the pharmaceutical industry at their site based in Hertfordshire on a permanent basis.

The Company:
Our client is a global Pharmaceutical company who place patients and their families at the forefront of everything they do.

The Location:
The role is based at our client's site in Hertfordshire which is commutable from many towns from Middlesex to Cambridgeshire. There are good road and public transport networks and London is easily reachable.

Quality Systems Associate - Qualification and Administration Role:
The main purpose of the role will be to:

• Ensure that electronic systems within the Quality Control Laboratory and the Quality Systems operate in accordance with the requirements of the departmental Standard Operating Procedures.
• Act as an administrator for the eQMS and QC laboratory system and ensure that these as well as software used to support the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and Corporate expectations.
• Support the Qualification and Validation of equipment, processes, systems to ensure performance in line with procedures, GMP and GAMP guidelines for process, equipment and electronic systems.
• Support Provision of training on the requirements for CSV and IT qualification and validation and review and approve Qualification and Validation documentation.

Your Background:
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

• Educated to degree level or above in a scientific field with industry experience and a working knowledge of Quality Control Systems, analytical software and electronic Quality Systems in the pharmaceutical industry.
• Extensive knowledge of electronic systems, CSV and GAMP requirements and a good understanding of the requirements of data integrity and application to system management.
• The ability to understand and analyse user requirements to facilitate changes and system improvements as well as knowledge of the qualification and validation requirements for equipment and electronic systems.

Apply:
For more information or to apply for this Quality Systems Associate - Qualification and Administration position, please contact Mary Bolt on 01246 457729 or email mbolt@ckgroup.co.uk quoting job ref 51488.

It is essential that applicants hold entitlement to work in the UK.

INDGEN