Regulatory Compliance and Quality Assurance Professional

5 days ago


Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time

In this role, you will work closely with site management to foster a culture of quality, providing guidance on GMP principles and their application. You will also be responsible for mentoring peers towards achieving organizational and individual goals.

Responsibilities:
  1. Collaborate with site management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
  2. Execute audit strategy and lead process audits to ensure regulatory compliance.
  3. Monitor quality to maintain inspection readiness and provide support during regulatory inspections or customer audits as requested.

You will have the opportunity to work on complex problems requiring in-depth evaluation of various factors from many sources. Interpretation of GMP regulations is essential in resolving problems and designing systems, processes, or procedures.



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