Reference Number: JO-2108-475014
Quality Systems Associate
Job Type: Permanent
This client is a global manufacturer of Pharmaceuticals, with a steady and growing QA team. They have excellent facilities and we are proud to be partnered with them.
As a Quality Systems Associate – Qualification and Administration you are 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.
Ensure EMLs Electronic TrackWise 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 Corporate expectations.
Provide input to the review and writing of any associated quality policies, systems and procedures as required
What are we looking for?
You will have:
- Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers
- Ability to understand and analyse user requirements to facilitate changes and system improvements
- Extensive knowledge of electronic systems, CSV and GAMP requirements
- Good understanding of the requirements of data integrity and application to system management
- Working knowledge of computer systems and CSV requirements
- Working knowledge of Quality Control Systems and analytical software and electronic Quality Systems
- Good technical and scientific judgement
- Ability to interpret complex data and present key findings
- Ability to describe technical information in easy-to-understand terms.
- Computer literate e.g. Word, Excel and PowerPoint
- Understanding of GMP Guidelines and Regulations
- Understanding of manufacture, packaging and testing of pharmaceutical products
- Knowledge of the qualification and validation requirements for equipment and electronic systems
- Maintain knowledge and understanding of technical advancements in electronic systems