Quality Systems Associate
Our client is a leading pharmaceutical company that is seeking a Quality Systems Associate to be based in Hertfordshire, UK.
This job is responsible for ensuring that operations carried out within the Quality Systems section are completed in accordance with the requirements of the departmental Standard Operating Procedures.
- A safe working environment is maintained for self and other employees, ensuring all near miss incidents and accidents are reported in accordance with procedures.
- The Quality of products manufactured and released is assured through adherence to all procedures.
- Opportunities to improve operations and reduce cost are identified and progressed through the continuous improvement and demand innovation initiatives.
- All stakeholder and customer expectations are understood and met through communication.
- Performance is in line with personal and company objectives with demonstrated behaviour's and competencies.
Details of responsibilities:
- Provide ongoing operation, maintenance and implementation of improvements to electronic systems
- Coordinate with external system providers for helpdesk support
- Coordinate system updates and upgrades with the system providers ensuring systems are maintained in a qualified state
- Coordinate with IT Team ensuring all systems are maintained in line with company policies
- Ensure procedures are in place for backup of data on electronic systems
- Generate qualification documentation in line with EML procedures
- Document and record all activities related to user errors in line with EML procedures
- Provide support to Quality Systems processes, SOPs, Training management
- To provide day to day support to other members of the Quality Systems team, as appropriate.
- Identify and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working
- To perform any appropriate duties at the request of the Senior Manager Regional Quality Systems
Skills and Competencies
- Able to maintain working relationships and communication links within EML, affiliated organisations.
- Basic knowledge of Quality Systems, GMP and basic understanding of manufacture and packaging of pharmaceutical products.
- Good technical and scientific judgement.
- Working knowledge of electronic systems and CSV requirements
- Understanding of GMP Guidelines and Regulations.
- Understanding of Computer Systems Validation (CSV) and GAMP
- Experience of ICT and business system lifecycle management preferably in a pharmaceutical manufacturing or other regulated environment
- Documentation and testing experience of ICT systems
- Broad range of knowledge in systems/applications relevant to pharmaceutical manufacturing
- A working knowledge and practical experience with writing SOPs and validation documentation (protocols/reports) as well as a knowledge of modern IT infrastructure.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please email Leoca Powell on firstname.lastname@example.org or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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