Duties & Responsibilities
* 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/PV’s with vendors.
* Tracks and maintains equipment schedule as per site procedures.
* Reviews and updates equipment SOP’s.
* Troubleshoots equipment and works with SME's to progress and resolve equipment issues.
* Performs work assignments accurately, and in a timely and safe manner.
* Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
* Coordinates and prioritizes project activities with internal functional groups and team leads in each of the QC laboratories.
* Procures, sets up, and maintains metrology and measurement systems/equipment.
* Generates SOP & WO for lab personnel, provides on-site training in lab documentation, cGMP, GDP & effectiveness assessments.
* Coordinates qualification, calibration, and maintenance activities with external vendors and liaises with them to schedule and arrange on-site visits.
* Manages and documents the storage and 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 as 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.
POSITION SPECIFICATION
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.
* Adheres to core values and behaviors.
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