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Quality Assurance Specialist

2 weeks ago

Dublin, Dublin City, Ireland Claran Consultants Ltd Full time

**Job Description:**

We are seeking a seasoned Quality Assurance Specialist to join our team at Claran Consultants Ltd. In this role, you will provide direct Quality support to production areas as part of a Quality IPT (Integrated Product Team).

The successful candidate will work closely with the Associate Director of Quality Operations to ensure quality and compliance of products manufactured by the functional area. This includes adherence to Good Manufacturing and Documentation Practices, representation of quality on the shop floor, and review of process documentation/data for accuracy, completeness, and data integrity compliance.

As a Quality Assurance Specialist, you will perform review of electronic batch records and logbooks to ensure accuracy and compliance with c GMPs and company procedures. You will also provide presence on the shop floor to support compliance and data integrity, review and approve new and updated SOPs/Work Instructions and Controlled Job Aides, and actively participate in the Tier process.

This is a shift role that requires a high level of flexibility, collaboration, and inclusion skills. The ideal candidate will have at least 5 years of working knowledge in the biotech industry with specific understanding of QA operations and regulatory agency engagement.

Key Responsibilities:

  • Review and approval of new and updated Master Batch Records / Electronic Batch Records
  • Review and approval of production documentation such as executed electronic batch records and logbooks
  • Provides presence on the shop floor to support compliance and data integrity
  • Review and approval of new and updated SOPs/Work Instructions and Controlled Job Aides
  • Active participation in the Tier process
  • QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment

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
  • Leadership skills coupled with good oral and written communication skills
  • Understanding of c GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills