A Validation Specialist is required to execute and report on PV/Process Performance Qualifications, as well as validation studies for equipment, systems and processes.
Key responsibilities include:
* Designing and executing validation studies
* Providing technical interpretation and guidance of current US FDA and EU validation requirements
* Maintaining validation documentation through the validation lifecycle
* Participating in external regulatory inspections and supporting Site Change Control process
The ideal candidate will have a degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering (Chemical/Mech/Elec), with previous validation/product development experience advantageous. Strong knowledge of Process Validation regulations, current industry practices and quality management systems is essential.
To succeed in this role, you should have excellent analytical skills, be able to communicate complex ideas clearly and have a detail-oriented approach.
We are looking for someone who can work independently and as part of a team, with strong problem-solving skills and the ability to meet deadlines.
This role offers opportunities for growth and professional development, working with a dynamic team and contributing to the success of our organization.