Validation Expert
The role of a Validation Expert is pivotal in ensuring ongoing validation compliance of computerized equipment and systems in sterile products manufacturing.
Responsibilities:
* Ensuring the validation of all new computerized equipment, and control systems.
* Developing and maintaining validation documentation (protocols/reports) and providing assistance with the execution of protocols for computerized equipment and systems.
* Participating in the change control process by advising on CSV issues, as appropriate.
* Executing hands-on DQ, IQ, OQ and PQ activities to ensure they are compliant with Company and legal requirements.
* Managing projects to ensure compliance with all required regulations (Health & Safety, cGMP, construction, environmental etc).
The Validation Expert designs, implements and executes validation studies for manufacturing and control equipment. Additional responsibilities include critical systems and facilities as well as validation studies to satisfy regulatory compliance.
Qualifications:
* Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
* Post-graduate studies as appropriate to augment primary Degree
* 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