职位描述
Responsibilities:
- Lead the validation activity for the process / cleaning validation etc., including: developing the detail validation strategy & approach, and validation / experimental data analysis under some statistical tools if necessary
- Investigate any issues encountered during routine production; provide a technical evaluation of the issue, conduct any studies required to provide supporting evidence and lead any required changes to the process / product
- Perform an ongoing review of the process and products to identify any trends / signals and take appropriate actions to ensure the process stays in control
- Identify opportunities for improvement/lean in the production process / review others ideas for suggested improvements in the production process and implementation of any such changes
- Create / update SOP or Guidelines for the validation principles or to clarify the group standard way of working
- Create / update BPRs
- SAP master date maintain if applicable
- Validation / process development documents e.g. PV, CV etc.
- Manage projects to support site business development, e.g. new product introduction, technical transfer, supply switch over, production line expansion, continuous improvement, etc.
Requirements:
- University graduate or above
- Familiar with the Pharmaceutical knowledge; including production processes
- GMP knowledge
- Familiar with the knowledge of process and cleaning validation
- Excellent written / oral English
- High level of computer skills
- Basic statistical knowledge
- Regulatory knowledge
- At & above the AZ 6 leadership capacity requirement for each level
- A3 report/FEMA, etc. tools used for problem solving
