LSC have a great contract opportunity for a Quality Auditor to join a leading biotech company based in Dublin.
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 cGMPs 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 1G/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