Description
Main responsibilities- Support the Quality Control and Process Sciences departments by maintaining their laboratory instrumentation in an operational, qualified state.
- This entails ensuring both instrument hardware and software qualifications are completed in a timely manner and keeping them in a qualified state.
- Establish best in class IQ/OQ/PQ processes and execution for laboratory instrumentation and controlled temperature units.
- Develop and write protocols for instrument qualification/validation studies.
- Assist in performing instrument qualification/validation experiments.
- Help troubleshoot instrument performance issues.
- Work with the vendor to schedule and complete necessary repairs.
- Complete instrument related documents on behalf of QC.
- Collaborate with Engineering/Metrology department to ensure equipment
calibrations are completed on time. - Develop a working knowledge of all software platforms in QC and troubleshoot them as necessary - for example Empower, SoftMax Pro.
- Experience with executing IQ/OQ/PQ protocols and administering software databases and working knowledge of change control in the pharmaceutical industry would be advantageous.