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/PV’s with vendors. * Tracks and maintains equipment schedule as per site procedures. * Reviews and updates equipment SOP’s. * 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