Job Outline:
- To assist the senior, including TS Executive/ Engineer in executing the validation and qualification activities, including Process Validation and Product Hold Time Study, Cleaning Validation or Performance Qualification of Equipment and Purified Water System. Execute the planned activities as per Validation Master Plan.
- To assist the execution of validation program as assigned 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.
- To support TS Executive/ Engineer during execution of Technology Transfer and scale up activities. This including New Product Launching, Revamp of new pack size/package design and Product/Process improvement activities.
Duties and Responsibilities:
- To support smooth operation of validation and qualification activities in plants by providing technical assistance 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.
- To assist the execution of planned Cleaning Validation activities according to Validation Master Plan.
- To assist during the coordination of activities with all departments during execution of technology transfer and scale-up, validation and qualifications activities.
- To provide swab and rinse sampling training to technician from cross-functional department and coordinate the training evaluation by performing recovery studies.
- To follow-up with Production for production schedules of planned validation and qualification activities.
- To check and ensure clear labeling of validation and qualification samples to prevent mix-up.
- To support the compilation of comparative quality evaluation report between current and alternative sources of materials for review by TS Executive and Technical Services Unit Manager.
- To provide data and documentation supports to Technical Services Unit Manager during initiation of change control.
- To support the training to production shop floor personnel after process validation, cleaning validation and performance qualification activities.
- 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.
- To participate and contribute during continuous product and process improvement projects and support other types of problem solving activities.
- To assist in training and supervising the technicians in carrying out their duties during validation sampling.
- To ensure timely technical support to existing or new projects as assigned from time to time.
- To inform superior immediately if detect any abnormality, deviation or anomaly condition during the validation and qualification activities.
Minimum Requirements:
- Bachelor Degree in Science, Engineering or Technical related discipline.
- Fresh graduate with Bachelor Degree in Science and Technical related discipline.
- Possess learning ability and resourceful to gain the knowledge of cGMP’s, pharmaceutical technology and processes, equipment, validation and qualification aspects.
- Some experiences in one or more of the following areas: Solid dosage manufacturing, Liquids, Creams and Ophthalmic manufacturing and Packaging processes is preferred.
- Good interpersonal skills to interface with executives, technicians and shop floor personnel.
- Good communication skills, both written and verbal is preferred.