- Reference: CJ43855y
- Job Type: Permanent
- Location: Limerick, Limerick City, Munster
- Category: Science, Pharmaceutical & Food
The main purpose of this role is to support the Quality Control (QC) and Process Sciences (PS) 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.
Duties and Responsibilities
- 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.
Education and Experience:
- Requires BS/BA in Chemistry or Biology; may consider another degree discipline with relevant experience
- 3 – 5 years relevant experience in a cGMP environment is required
- Experience with executing IQ/OQ/PQ protocols and administering software databases and working knowledge of change control in the pharmaceutical industry would be advantageous
For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email email@example.com
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