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QA Specialist

Boehringer Ingelheim

Boehringer Ingelheim

Software Engineering, Quality Assurance
Shanghai, China
Posted on Tuesday, June 4, 2024
About Human Pharmaceutical Business

With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.

Accountabilities:

  • Provide the timely QA support for deviations root cause investigation, CAPA plan setting and follow up,Local new product launch .
  • Ensure the SOP execution comply with company’s and GMP regulation trough onsite inspection check.
  • Update SOP related to Product quality function according to business needs and regular review to ensure comply with GMP and BI global requirement.
  • Ensure timely completion of owned Product Quality Review for product
  • To evaluate batch records and to ensure that the batch records are reviewed before product release delegated by QP; And then release product in system.
  • As QP delegate, responsible for status change of finished goods and material (after QC usage decision) in system.
  • As local MSO for related quality systems or local key user for related system, responsible for Gap analysis, related Doc. update and training, routine execution and conduct continuous improvement.
  • As SME in change project to ensure the project compliance with GMP regulation
  • Provide quality support for responsible area, ensure operation in compliance with regulation and procedure.


Requirements

  • Good knowledge of GMP
  • Familiar with related local regulations
  • Pharmacy of relevant
  • Good knowledge of related technology,guidelines and standards
  • Good English skills