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Pharmaceutical Packaging Systems Project Manager

2 weeks ago


Melbourne, Victoria, Australia beBeePackaging Full time $100,000 - $120,000

Job Title: C&Q Engineer

Commissioning and Qualification of Packaging Equipment

We are seeking a highly experienced Project Manager to lead the commissioning and qualification activities for packaging equipment. The successful candidate will have extensive experience in validating the functionality and performance of pharmaceutical packaging systems.

Key Responsibilities
  • Lead Commissioning Activities: Supervise the execution of commissioning activities to ensure that packaging equipment meets regulatory guidelines.
  • Qualify Systems: Validate that packaging systems meet GMP, GAMP 5, and other relevant regulatory requirements.
  • Author and Review Documents: Create and review documents such as User Requirements Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Manage Risk and Deviations: Conduct risk assessments and manage deviations and change controls effectively.
Requirements
  • Regulatory Knowledge: Strong understanding of regulatory guidelines, including GMP and GAMP 5.
  • Packaging Experience: Experience with pharmaceutical packaging equipment and clean utility systems.
  • Technical Writing Skills: Excellent technical writing and communication skills.
  • Independent Work: Ability to work independently and manage multiple priorities in a dynamic environment.
About the Role

This role offers an excellent opportunity to utilize your expertise in commissioning and qualification of packaging equipment. If you are a skilled project manager with a passion for regulatory compliance, we encourage you to apply.