Technical Facilitator
AstraZeneca
Wuxi, Jiangsu
2天前

Lead the validation activity for the process / cleaning validation etc. It is to include :

  • Developing the detail validation strategy& approach
  • 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.
  • Compliance with AZ code of conduct and SHE requirement.
  • Requirements :

  • University graduate or above
  • Familiar with the Pharmaceutical knowledge; including production processes
  • GMP knowledge
  • Familiar with the knowledge of process and cleaning validation
  • Exellent written / Oral English
  • High level of computer skills
  • Basic statistical knowledge
  • Regulatory knowledge
  • At & above the AZ 6 leadership capacity requirement for each level
  • At least 7 years’ experience in pharmaceutical technology
  • A3 report / FEMA, etc tools used for problem solving
  • AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.

    We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.

    We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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