Description
Role overview:- Completes Document Preparation and Field Execution activities for the initial qualification activities for laboratory and/or Manufacturing equipment.
- Implements the qualification program for initial qualification of laboratory and/or manufacturing equipment.
- This includes document preparation for:
- Equipment Qualification Assessments (EQAs).
- Installation Qualifications (IQs), Operational Qualifications (OQs), and where applicable Performance Qualifications (PQs).
- Summary Reports (SRs), Trace Matrices (TMs).
- This includes execution for IQ, OQ and where applicable, PQ.
- Maintain progress trackers for document prep and execution activities.
- Attend daily co-ordination meetings with the Area Lead/QAVAL specialist/Associate Manager.
- Proven experience in qualification of lab and/or manufacturing equipment, ideally in a bulk biologics start-up environment.
- A clear understanding of cGMP requirements of laboratory and/or manufacturing equipment and qualification.
- Previous experience in a biopharmaceutical or pharmaceutical environment is required.
- The QAV Specialist will be required to work on his/her own initiative as much as working as part of a team.
- The successful candidate must be able to demonstrate excellent time management and organisational skills along with a proven ability to multi-task.