Cleaning Validation Expert
We are seeking a seasoned Cleaning Validation Expert to lead our validation efforts in Cork, Ireland.
This is an extended contract opportunity that involves working on multiple aspects of cleaning validation, including generating validation impact assessments, reviewing change controls, and updating documentation.
The ideal candidate will possess exceptional analytical and problem-solving skills, with the ability to work effectively in a collaborative environment. They will also have strong communication and training skills, with the ability to deliver training sessions on process performance qualification and process validation protocols.
Key Responsibilities:
* Generation of validation impact assessments (VIA)
* Review of change controls
* Creation of process validation plans
* Development of cleaning validation plans
* Update of cleaning validation and process validation documentation impacted by changes
* Cleaning technical assessment
* Process flow of products/equipment at the facility
* Cleaning validation matrix
* Generation of process performance qualification (PPQ) and process validation (PV) protocol(s)
* Execution of process validation protocol (PPQ/PV) activities
* Delivery of training on PPQ/PV protocols
* Generation of PPQ and PV reports
* Review/approval of project failure mode effect analysis (FMEA)/technical assessments as required
* Execution of cleaning validation as per cleaning validation plan/protocol(s)