Quality Auditor
1 week ago
If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you ABOUT THE PROJECT - KEY RESPONSIBILITIES: Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with c GMPs and company procedures Provides presence on the shop floor to support compliance and data integrity Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
ABOUT YOU - ARE YOUR SKILLS A MATCH? 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.
This role requires a seasoned professional with the expertise 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.
Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1 G/Stamp 4 visa to apply Apply via this advert or contact Cian Marnane at LSC on if you have any more questions about this role Skills: Documentation Quality Assurance Change Controls
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