Quality Systems Associate - Qualification and Administration

Quality Systems Associate - Qualification and Administration

12 month FTC

Hatfield

Negotiable Salary

Cpl Life Sciences are currently partnering with a global pharmaceutical company that supports with all areas of the process of new/ current medicines from R&D to marketing recruiting for a Quality Systems Associate. 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. This role has a heavy focus around electronic systems, CSV, and GAMP requirements.

Key Responsibilities:

• Support client’s electronic QMS and QC laboratory electronic systems as administrator

• Provide ongoing operation, maintenance, and implementation of improvements to electronic systems to support company needs.

• Support system updates and upgrades with the system providers ensuring systems are maintained in a qualified state.

• Support the Implementation of system upgrades and new software applications.

• Provide support to QC Analysts to ensure software and file changes are managed in line with data integrity and company procedure requirements.

• Prepare and update SOPs and training materials for system administration activities for QC instrumentation and other electronic systems.

• Support the ongoing operation, maintenance, and implementation of improvements to TrackWise processes and systems to meet company needs.

• Write and review all SOPs associated with the electronic QMS. 

• Support 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. 

Skills:

• Ability to establish and maintain effective working relationships and communication links within the company, affiliated organisations and other customers.

• Ability to understand and analyse user requirements to facilitate changes and system improvements.

• Working knowledge of electronic systems, CSV, and GAMP requirements

• Good understanding of the requirements of data integrity and application to system management

• Working knowledge of Quality Control Systems and analytical software and electronic Quality Systems

Please apply within for more information or send your CV to [email protected]