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Quality Systems Expert

2 weeks ago

Dublin, Dublin City, Ireland Claran Consultants Ltd Full time

**Role Overview:**

We are seeking a highly skilled Quality Systems Expert to join our team at Claran Consultants Ltd. As a key member of our Quality department, you will be responsible for ensuring quality and compliance of products manufactured by our functional area.

The successful candidate will work closely with the Associate Director of Quality Operations to develop and implement effective quality systems and processes that meet regulatory requirements. This includes review of process documentation/data for accuracy, completeness, and data integrity compliance, as well as provision of guidance to the Quality IPT (Integrated Product Team).

As a Quality Systems Expert, you will oversee the review and approval of new and updated SOPs/Work Instructions and Controlled Job Aides, and actively participate in the Tier process. You will also provide technical expertise to junior team members, and contribute to the development of quality-related policies and procedures.

Key Responsibilities:

  • Develop and implement effective quality systems and processes that meet regulatory requirements
  • Review and approval of new and updated SOPs/Work Instructions and Controlled Job Aides
  • Actively participate in the Tier process
  • Provide technical expertise to junior team members
  • Contribute to the development of quality-related policies and procedures

Required Skills and Qualifications:

  • Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations
  • Seasoned professional with expertise in QA operations and regulatory agency engagement
  • Technical expertise in quality systems and processes
  • Understanding of c GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area