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Pharmacy Systems Specialist
1 month ago
PURPOSE OF THE JOB:
Responsible for the management of pharmacy equipment and systems in accordance with applicable regulatory requirements, such as Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP). This includes equipment and system commissioning, qualification, validation, calibration, maintenance, and management of change and deviation.
CORE JOB TASK
- Develop and execute equipment qualification and validation plans and protocols.
- Conduct routine review of qualification and validation processes and documentation.
- Ensure timely calibration and corrective/preventive maintenance of equipment.
- Develop and maintain equipment database, including the pharmacy master equipment list, activity trackers, and equipment records and data files.
- 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, including procurement of accessories and consumables, management of service contracts, provision of qualification, validation, calibration, and maintenance services, and troubleshooting activities.
- Liaise with other stakeholders (e.g. IT, ST, global Lilly engineer) for other equipment and system needs.
- Manage equipment lifecycle, and plan for new equipment needs or old equipment replacement/retirement in line with corporate priorities and business goals.
- Manage equipment inventory, including accessories and consumables.
- Raise and follow through change requests for equipment changes according to the change management system.
- Perform investigation into equipment deviations and follow through with CAPA according to the deviation management system.
- Perform pharmacy operational activities such as cleaning of pharmacy equipment and areas, and environmental monitoring.
- Assist with process validations if required.
- Serve as SME for pharmacy equipment and provide equipment training to pharmacy personnel.
- Performs cross-functional and other duties as assigned by the supervisor.
Regulatory Compliance
- Adheres to Singapore Guideline for Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Documentation Practice and other applicable regulatory requirements.
- Adheres to global and local policies and procedures.
- Adheres to Quality Agreement(s).
- Reviews, updates and implements local standard operation procedures as appropriate.
- Participates in applicable audit and inspection visits by Lilly and external agencies and ensures quality issues are resolved.
REQUIRED QUALIFICATIONS AND EXPERIENCE
- 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.
REQUIRED SKILLS
- Good interpersonal and communication skills.
- Meticulous and detail-oriented.
- Good organization and project management skills.
- Ability to work independently.
- Proficient in GMP and GCP (preferred).
OTHER INFORMATION
- Able to work in cleanroom environment, which requires special gowning procedures.
- May be required to support pharmacy activities out of office hours.
Management Skills
Troubleshooting
CAPA
Regulatory Compliance
Change Management
GMP
Investigation
Equipment Qualification
VMware Server
GCP
Regulatory Requirements
Life Sciences
Manufacturing
Audit
Commissioning
Service Delivery
