Quality Reviewer - Data Integrity
Role is based in Barnard Castle but initially working from Home
This will involve working in multi-disciplinary teams across site to review existing systems to ensure they are compliant with data integrity principles such as access control, password management, back up and audit trail. You will be providing advice to ensure that the assessment is carried out correctly and appropriately documented. You will do this through off-line assessment reviews and working sessions with Engineering and Production colleagues to agree appropriate wording, risk assessment and corrective actions.
The holder needs to have experience in:
- Experience in pharmaceutical quality departments working with manufacturing teams.
- Experience of data integrity principles and data integrity regulations
- Good planning, organisational and time management skills
- Ability to make decisions, solve problems, negotiate, influence and communicate effectively with others.
- Knowledge of pharmaceutical manufacturing equipment and processes or alternatively knowledge of controls and IT systems.
- Well developed verbal, written, numeric and presentation skills