Chemist - P2

Delivery of key Quality and Performance Objectives. Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP. Your responsibilities may include test method development and validation, raw material, in process, finished product and Stability testing. Ensure all analytical testing is carried out as defined in the Quality System. Perform equipment and qualification per USP <1058> Analytical Instrument Qualification and GAMP5: A Risk-based Approach to Compliant GxP Computerized Systems as required. Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required. Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records. Perform and assist with additional duties as may be directed by the Lab Management. Provide analytical support to process validations. Management of laboratory inventory and supplies and ordering of same. Participate on LBP/VIP/Quality Catch/Preventive CAPA and Continuous project teams as required. Coordinate Preventive Maintenance and Calibration activities for equipment and ensure no event of Calibration/PM overdue. Participate in OOS investigations, utilizing technical knowledge to identify assignable cause and corrective actions. Manage/handle lifecycle management of an equipment, i.e., Procurement, Commissioning, Qualification Maintenance, Calibration, troubleshooting, availability of contingency equipment and Retirement of the equipment and software. Perform all in-house (Lab scope) Calibration, Preventive Maintenance, Temperature Mapping, Software Maintenance (scheduled data backup, disaster recovery exercise and data archival). Initiate and own NCEP/CAPA as per required. Proficient in the use of various software application utilized in the laboratory, i.e LIMS, Waters Empower. Experience in LIMS set-up and empower software is preferable.