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Job Description
Job Summary: Laboratory Equipment Specialist responsible for calibration, maintenance, and qualification of analytical equipment, ensuring compliance with site procedures and regulatory guidelines.
Coordinates and performs calibration and maintenance activities on a range of analytical equipment as per site procedures.
- Coordinates and performs equipment qualifications, executing IQ/OQ/PQ activities for routine PM/PVs with vendors.
- Tracks and maintains equipment schedule as per site procedures.
- Reviews and updates equipment SOPs.
- Troubleshoots equipment and works with SMEs to progress and resolve equipment issues.
- Performs work assignments accurately, and in a timely and safe manner.
- Coordinates and prioritizes project activities with internal functional groups with each of the QC laboratories and team leads.
- Procures, sets up, and maintains metrology and measurement systems/equipment.
- Generates SOP & WO for lab personnel, on-site training in lab documentation, cGMP, GDP & effectiveness assessments.
- Coordinates qualification, calibration, and maintenance activities with external vendors and liaises with Vendors to schedule and arrange on-site visits.
- Manages and documents the storage, archiving of instrument data.
- Manages and prioritizes lab duties to minimize risk and meet deadlines in a high volume fast-paced environment.
- Provides technical reports on instruments where required.
- Delivers technical presentations on various equipment as required.
- Participates in and supports GMP regulatory audits to ensure department compliance/readiness.
- Participates in continuous improvement activities within the QC Group and with other functions.
Qualifications, Experience, Skills, Knowledge and Attributes:
- At least 2-3 years relevant experience in validation of laboratory equipment.
- Experience with SAP.
- 2 years experience working with laboratory equipment.
- Qualification/validation of equipment.
- Good knowledge of regulatory guidelines relating to analytical equipment and validation.
- Knowledge of key suppliers of analytical equipment and materials.
- Adherence to core values and behaviors.