We are seeking a skilled Validation Specialist to join our team in an exciting opportunity with a Pharmaceutical organization based in Carlow. This is an excellent position for anyone who wants to work with a leading multinational and be part of their quality assurance process.
About the Job
The successful candidate will execute cleaning cycle development and performance qualification of equipment, write and adhere to validation strategies, coordinate with outside vendors, write protocols independently, submit samples, analyze test results, and prepare technical reports.
In addition, they will run business activities such as equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments, and provide support during commissioning phase by reviewing and approving documents.
Required Skills and Qualifications
* Experience as a validation specialist in a pharmaceutical or highly regulated environment.
* Bachelor's Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field.
* Working knowledge of GxP systems associated with this role, including GLIMS and eVAL, electronic batch records.
Benefits
This role offers the opportunity to work with a leading multinational and be part of their quality assurance process. The successful candidate will have a working knowledge of the latest regulatory guidelines and be able to represent the team on cross-functional project teams.
Others
The ideal candidate will have experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.