About Us:
The CSV Specialist plays a crucial role in ensuring the ongoing validation compliance of computerised equipment and systems in sterile products manufacturing.
Key Responsibilities:
* Integral involvement in the validation of all new computerised equipment, and control systems
* Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerised equipment and systems
* Participates in the change control process advising on CSV issues, as appropriate
* Hands-on role in the development and execution of DQ, IQ, OQ and PQ activities
* Ensures projects are managed in compliance with all required legal requirements (Health & Safety, cGMP, construction, environmental etc)
* Designs, implements and executes validation studies for manufacturing and control equipment
* Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance
* Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing and sterilisation
* Ensure that the validation status of equipment and systems are in compliance with cGMP at all times
* Maintain validation documentation through the Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans Generate/review/approve execution of the validation/revalidation plans Review and approval of site change controls Ensure compliance to cGMP at all times
Qualifications:
* Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
* Post-graduate studies as appropriate to augment primary Degree
Experience:
* 3-5 years experience working in a Healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector
* 2-3 years experience in validation environment
* Project management experience
Skills and Knowledge:
* 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
* Full understanding of relevant quality and compliance regulations
* Able to execute projects to plan
* Good knowledge of quality management systems
* Effective facilitator
* Good communication skills at organisation, team and individual levels
* Understands KPIs for the site