Data Integrity Specialist
Location Newcastle upon Tyne
Salary £28,000 - £34,000
Are you a chemical analyst with experience of supporting site systems and data Integrity?
If so, we have a great opportunity for further individual development and to join a leading pharmaceutical Contract Development and Manufacturing Organisation (CDMO). This role is key role to be based our client’s site near Newcastle upon Tyne.
Working as the Data Integrity Specialist for this location, you will play an important role in ensuring laboratory systems, equipment and procedures are compliant and meet the requirements of Data Integrity.
You will support the sites:
- Administration of laboratory systems, and to provide a quality system to ensure use within regulatory guidelines
- Review Lab based systems and standalone systems to ensure compliance
- Implement system action plans were required
- Support during customer audits and regulatory inspections with regards to Data Integrity
- Develop knowledge of the lab systems to provide continuous improvement
- Provide support to QA to enable audits of laboratory and production computerized systems to be effective.
- Understanding of 21 CFR Part 11, GAMP 5 and MHRA GMP Data Integrity Definitions and Guidance for industry
- Previous experience and training on analytical software packages database systems and laboratory informatics
- Knowledge of GMP, validation and regulatory issues
- Good written and verbal communication skills
In return, you will get the opportunity to work with a growing and developing organisation in an exciting sector. You will receive a competitive salary, and benefits package including 27 days holiday plus statutory holidays, and more.
If you’re interested, call Owain today on 07851 246839 for an informal chat, or Apply with your CV.