Pharmacy System Specialist
2 weeks ago
**Job Summary:**
We are seeking a skilled professional to develop and execute equipment qualification and validation plans, ensuring timely calibration and maintenance of equipment. The successful candidate will conduct routine reviews of qualification and validation processes and documentation.
Key Responsibilities:- Develop and execute equipment qualification and validation plans
- Conduct routine reviews of qualification and validation processes and documentation
- Evaluate and implement corrective actions to ensure compliance with regulatory requirements
- Liaise with internal stakeholders to schedule equipment activities with minimal impact on operational activities
- Liaise with external stakeholders to ensure timely equipment procurement and service delivery
- Manage equipment database, including the pharmacy master equipment list, activity trackers, and equipment records and data files
- Ensure adherence to Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and other applicable regulatory requirements
- Diploma or Degree in Life Sciences, Engineering, Information Systems, or Computer Systems
- Preferably with equipment and systems commissioning, qualification, and validation experience
- Preferably with GMP, biomedical, and/or clinical research experience
- Able to work in a cleanroom environment, which requires special gowning procedures
- May be required to support pharmacy activities out of office hours
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