Process, Validations, Qualification 1. To execute the planned the activities for selection and evaluation of new or alternative source of raw and packaging materials. 2. To support Technical Services Executive I during execution of validation program for process/ product validation, performance qualification for new equipment/ machineries and cleaning validation activities. These include activities of sampling, arrangement of validation samples for physical and chemical testing, follow-up of results and compilation of validation data and reports for review and approval. 1. To support smooth operation of validation and qualification activities in plants to Technical Services Unit Manager by providing technical support during sampling and inspection activities, follow-up of testing results, compilation of validation and qualification results and outcomes, and assist in preparation of validation and qualification reports. 2. To provide swab and rinse sampling training to technician from cross-functional department and coordinate the training evaluation by performing recovery studies. 3. To assist the revision and update of the Validation Master Plans for Process Validation (PV) and Product Hold Time Study (HTS) for management review and approval. 4. To follow-up with Production for production schedules of planned validation and qualification activities. 5. To ensure clear labelling of validation and qualification samples to prevent mix-up. 6. To support the material evaluation activities by coordinating the material samples for physical and chemical testing. 7. To compile the comparative quality evaluation report between current and alternative sources of materials for review by Technical Services Executive I. 8. To provide data and documentation supports to Technical Services Executive I during initiation of change control. 9. To support the training to production shop floor personnel after process validation, cleaning validation and performance qualification activities. 10. To support in operation qualification and performance qualification of new processing and packaging equipment and execute the test run of samples for new packaging components. 11. To provide technical support and collection of resourceful information on technical areas as requested by Technical Services Executive I. 12. To participate and contribute during continuous product and process improvement projects and support other types of problem solving activities. 13. To assist in training and supervising technicians in carrying out their duties during validation sampling. 14. To ensure timely technical support to existing or new projects as assigned from time to time. 15. To inform superior if detected any abnormality, deviation or anomaly condition during the execution of validation and qualification activities
Founded in 1967 in Singapore, Xepa has grown and evolved at the cutting edge of the industry. From our modest first years when Xepa Laboratories Pte. Ltd. produced a limited range of pharmaceutical products in a small flatted factory, we have relocated twice to larger manufacturing plants in Melaka, Malaysia. Today, Xepa is the leading manufacturer of off-patent pharmaceuticals in Malaysia.
Bachelor\'s or Equivalent