Regulatory Compliance Expert

3 days ago


Dublin, Dublin City, Ireland Claran Consultants Ltd Full time

Company Overview

Claran Consultants Ltd is a leading consulting firm that specializes in providing quality assurance and regulatory compliance services to the pharmaceutical and biotechnology industries.

Job Summary

We are seeking a highly experienced Quality Assurance Specialist to join our team. The successful candidate will have a proven track record of ensuring the quality and compliance of products manufactured by production areas, adhering to Good Manufacturing Practices (GMPs) and regulatory requirements.

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
  • Providing 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
  • Participating in Tier process and making issues visible and partnering with the functional area on resolution
  • QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment
  • Serving as the Quality SME for Performance qualification (PQ) activities across the site
  • Participating as the quality member on cross-functional projects
  • Supporting sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review

Requirements:

  • 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 and working knowledge in the biotech industry, specifically understanding of QA operations and regulatory agency engagement
  • Evidence of leadership skills coupled with good oral and written communication skills
  • Understanding of cGMPs and regulatory requirements as they apply to the pharmaceutical field or a related area


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