QA CONTINUING VALIDATION SPECIALIST required by CareerWise Recruitment for our multinational BioTech client in the mid-west (Ireland). 12 month contract on offer.
The QA CONTINUING VALIDATION SPECIALIST will have good communication skills, have an Analytical mind set and can work independently. They will also lead investigations and need to have CTU/WH fridges/freezer/incubators/warehouse qualification experience.
Role of this position
- Experience in Continuing Validation (re-validation or maintain a qualified state in relation to equipment/Utilities).
- Experience in gap analysis assessments
- Experienced technical writer
- Experience in Deviations/Change control writing
- Experience in continuing assessments of equipment
- Capable of managing a large program, so project management skills would be necessary
- An excellent understanding of how manufacturing/Cleaning Validation/HVAC equipment works
- Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ protocalls, Tracematrix, Summary Report and drive post-approval of same.
- Interface with Commissioning, Process Sciences and Manufacturing teams
- Experience in Document Preparation and Execution
- Experience in major start-ups where construction, C&Q, PQ may be concurrent activities.
- Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing.
- Have Troubleshooting and analytical mindset.
Please call Conor Twomey today for further information on 021 4297422 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)