Lab Instrumentation Specialist-Perm
GMP experience essential
A fantastic opportunity has arisen for a Lab Instrumentation Specialist to carry out Instrument Qualification/Validation within a QC Lab .
This company has much to offer its employees:
- A career development and training programme that allows employees to expand their skills and abilities to keep up with changing technology.
- Fast track training opportunities.
- A good range of benefits - Pension, Life Assurance, Permanent Health Insurance, Bonus Scheme, Educational Assistance, Employee Assistance Programme, etc.
- 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.
- Tabulate results and write summary reports of instrument and software uses and qualification studies.
- Help to organize the new instrument evaluation and purchase activity.
- Present status updates at group and possibly at interdepartmental meetings.
- Produce and maintain accurate and GMP compliant records.
- Write SOPs relevant to laboratory instrument and software operation.
- May perform routine quality control in-process, release, and stability testing, as needed.
- BSc. BA in Chemistry or Biology
- 3 - 5 years relevant experience in a cGMP environment is essential
- Experience with executing IQ/OQ/PQ protocols
- Administering software databases and working knowledge of change control in the pharmaceutical industry would be benefical
For more information please call Felicity 086 7821714
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