A Data Validation Specialist is a crucial professional ensuring the validation compliance of computerized equipment and systems onsite.
Responsibilities include:
* Being integrally involved in the validation of all new computerized equipment, and control systems onsite
* Generating validation documentation (protocols/reports) and helping with the execution of protocols for computerized equipment and systems
* Participating in the change control process, advising on CSV issues as appropriate
* A hands-on role in the development and execution of DQ, IQ, OQ and PQ activities
* Ensuring projects are managed in compliance with all required legal requirements (Health & Safety, c GMP, construction, environmental etc)
* Designing, implementing and executing validation studies for manufacturing and control equipment
* Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance
* Providing technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing and sterilisation
The incumbent ensures that the validation status of equipment and systems are in compliance with c GMP at all times
Maintaining validation documentation through the approval and implementation of changes to relevant systems and assisting in generating validation/ revalidation plans
Qualifications & Experience: A degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
3-5 years experience working in a Healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector and 2-3 years experience in validation environment
Project management experience
Capable of troubleshooting validation issues associated with projects, process development etc
Competent technical knowledge of pharmaceutical plants
Knowledge of requirements for GAMP, ISPE Baseline guides
A full understanding of relevant quality and compliance regulations
Good knowledge of quality management systems