Quality Assurance Specialist
LSC has a fantastic contract opportunity for a Quality Assurance Specialist to join a leading biotech company based in Dublin.
This role could be the perfect chance for you if you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge.
About The Project - Key Responsibilities:
* Review and approve new and updated Master Batch Records / Electronic Batch Records to ensure accuracy and compliance with cGMPs and company procedures.
* 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.
* Actively participate in the Tier process and use 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 expertise in 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.