Job Description
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/PVs with vendors. Tracks and maintains equipment schedule as per site procedures. Reviews and updates equipment SOPs. Troubleshooting equipment and work 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. Coordinate and prioritize project activities with internal functional groups with each of the QC laboratories and team leads. Procurement, set-up and maintaining metrology and measurement systems/equipment. Generation of 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. Manage and document the storage, archiving of instrument data. Management and prioritising lab duties to minimise risk and meet deadlines in a high volume fast paced environment. Provide technical reports on instruments where required. Deliver technical presentations on various equipment as required. Participate in and support GMP regulatory audits to ensure department compliance/readiness. Participate in continous 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. Adhere to core values and behaviours.