- To drive the GxP training deployment at site to ensure the personnel performing work affecting product quality is competent in terms of knowledge and skills. This included but not limited to the below:Identify needs for training, d
- Design training and measure impact to organization / manufacturing process
- Initial qualification and requalification of personnel for GxP areas/processes (as per risk assessment)
- To review and drive improvements continuously in the GxP training deployment at site which included but not limited to training materials, training methods, training monitoring and trainer competency.
- To support key projects roll out at site from training perspective which have impact to GxP workGxP
- To drive the GxP record management at site to ensure the controls are in place for the identification, storage, security and integrity, retrieval, retention time and disposition of GxPrecords (throughout record life-cycle).
- To review and drive improvements continuously in the GxP record management
- Degree holder in any field.
- Minimum 5-7years’ experience in GxP regulated manufacturing or comparable.
- ≥ 2 years supervisory experiences incl people managing responsibility.
- Experience in developing, implementing and monitoring quality systems projects.
- Ideally have experience in leading training functions.Ability to identify needs, design training and measure impact.
- Proven training experience both hands-on and classroom in a GMP manufacturing environment.
- Having the knowledge in regulatory requirements for training and records is preferable.
- Possess the record management experience will be an advantage.
- Demonstrates strong written and verbal communication skills(min English), allowing effective interaction with all levels of the organization.
- Able to create relevant options for addressing problems/opportunities identified.
- Collaborative personality with strong passion to work in a team and capable to interact with all levels of management
- Additional knowledge/experience in Quality Systems like VEEVA, DOCUMENTUM, TRACKWISE will be an advantage.