Duties & Responsibilities
1. Coordinates and performs calibration and maintenance activities on a range of analytical equipment as per site procedures.
2. Coordinates and performs equipment qualifications, executing IQ/OQ/PQ activities for routine PM/PV’s with vendors.
3. Tracks and maintains equipment schedule as per site procedures.
4. Reviews and updates equipment SOP’s.
5. Troubleshoots equipment and works with SMEs to progress and resolve equipment issues.
6. Performs work assignments accurately, and in a timely and safe manner.
7. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
8. Coordinates and prioritizes project activities with internal functional groups within each of the QC laboratories and team leads.
9. Procures, sets up, and maintains metrology and measurement systems/equipment.
10. Generates SOP & WO for lab personnel, providing on-site training in lab documentation, cGMP, GDP & effectiveness assessments.
11. Coordinates qualification, calibration, and maintenance activities with external vendors and liaises with vendors to schedule and arrange on-site visits.
12. Manages and documents the storage and archiving of instrument data.
13. Manages and prioritizes lab duties to minimize risk and meet deadlines in a high-volume fast-paced environment.
14. Provides technical reports on instruments where required.
15. Delivers technical presentations on various equipment as required.
16. Participates in and supports GMP regulatory audits to ensure department compliance/readiness.
17. Participates in continuous improvement activities within the QC Group and with other functions.
POSITION SPECIFICATION
Qualifications, Experience, Skills, Knowledge and Attributes
1. At least 2-3 years’ relevant experience in validation of laboratory equipment.
2. Experience with SAP.
3. 2 years’ experience working with laboratory equipment.
4. Qualification / Validation of equipment.
5. Good knowledge of regulatory guidelines relating to analytical equipment and validation.
6. Knowledge of key suppliers of analytical equipment and materials.
7. Adhere to core values and behaviours.
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