Quality Audit Manager


Your new company

Your new role
  • Planning, Preparing, Conducting and Reporting of GMP/GDP and Quality system audits at Third party contractors (Finished dosage manufacturers, API manufacturers, key intermediate manufacturers, Excipients Manufacturers, Packaging Material Manufacturers, Contract Manufacturers, Contract Research Organizations) to monitor that all aspects of the operational business comply with applicable GMP / GDP legal and regulatory requirements (e.g. national and EU requirements), and the STADA Group Quality Standard in close cooperation with the Global Quality Supplier Management & Auditing Team located at STADA Arzneimittel AG Headquarter in Germany and STADA Hemofarm SRL in Romania.
  • Writing Audit Reports in line with the Global Quality Supplier Management & Auditing reporting Templates and Evaluation of audit result and reporting to Global Quality Supplier Management & Auditing
  • Close cooperation and alignment with other Regional Auditors

What you'll need to succeed
  • Bachelor degree or above, on pharmaceutical, chemistry, or related discipline
  • At least 3 - 5 years of experience in the pharmaceutical, biopharmaceutical or chemical industry in Production, Quality Assurance, Quality Control, or Development Department
  • Experience in auditing Third party contractors according to EU GMP Guideline Part I and Part II or equivalent (ICH Q7, national)
  • Experience in compilation and reviewing of Drug Master File (DMF) and other supplier qualification related documentation
  • Good interpersonal skills, organizational and time management skills
  • Good problem solving and risk assessment abilities
  • Fluent in speaking and writing English

What you'll get in return

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1226331


Job Type
Life Sciences
Closing date
31 Aug 2022

Talk to a consultant

Talk to Lennie Wang, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)

Telephone: +8602123229787

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