AstraZeneca Pharmaceuticals LP (Sr.) Process Engineer, Formulation in Wuxi, China

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