As a Data Validation Specialist, you will play a pivotal role in ensuring compliance with regulatory requirements and maintaining the integrity of equipment and systems.
Key Responsibilities:
* Integrate into the validation process for all new computerised equipment and control systems
* Generate documentation (protocols/reports) and assist with the execution of protocols for computerised equipment and systems
* Participate in change control processes, advising on CSV issues as necessary
* Conduct hands-on roles in development and execution of DQ, IQ, OQ, and PQ activities
* Ensure projects are managed in compliance with all required legal requirements
Additionally, you will be responsible for designing, implementing, and executing validation studies for manufacturing and control equipment. This includes critical systems and facilities, as well as validation studies to satisfy regulatory compliance.
You will also provide technical assistance on current FDA and EU validation requirements. Ensuring the validation status of equipment and systems remains in compliance at all times is a top priority.
Maintaining validation documentation through approval and implementation of changes to relevant systems and assisting in generating validation plans is essential. Reviewing and approving execution of validation plans, as well as reviewing and approving site change controls, are also key responsibilities.
Qualifications & Experience:
* Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
* 3-5 years of experience working in a Healthcare manufacturing environment, ideally part of which would be in the pharmaceutical sector, and 2-3 years of experience in validation environments
* Project management experience
* Capable of troubleshooting validation issues associated with projects, process development, etc.
* Competent technical knowledge of pharmaceutical plants
* Knowledge of GAMP and ISPE Baseline guides
* Full understanding of relevant quality regulations
* Good knowledge of quality management systems