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Quality and Compliance Expert

1 week ago

Dublin, Dublin City, Ireland Merck Gruppe - Msd Sharp & Dohme Full time
About Our Company

We are a leading global healthcare company, committed to advancing manufacturing excellence and R&D across our Irish sites and global company network.

We have a dynamic and diverse team of over 3,000 employees, working across seven sites in Ireland.

Job Overview

This is a unique opportunity to join our team as a Quality Assurance Specialist.

As a Quality Assurance Specialist, you will provide direct quality support to a production area as part of a Quality IPT.

You will ensure quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represent quality on the shop floor.

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, to ensure accuracy and compliance with cGMPs and company procedures.
  • Presence on the shop floor to support compliance and data integrity.
  • Review and approval of new and updated Standard Operating Procedures/Work Instructions and Controlled Job Aides.
  • Active participation in the Tier process to make issues visible and partner with the functional area on resolution.
  • QA support, review, and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
Requirements
  • Bachelor's degree in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.
  • 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 at least 5 years working knowledge in the biotech industry, with specific understanding of QA operations an advantage, as well as 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.
  • Demonstrated interpersonal skills, including flexibility, collaboration, and inclusion skills, and ability to work in a team environment.