Operations Shift Specialist

3 weeks ago

Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time
Operations Shift Specialist - Ireland, Dublin - 11 Months Initial Contract

Do you want to be involved with exciting pharmaceutical projects?

When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require an Operations Shift Specialist.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:

- 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
- Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
- QA support, review, and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.

Desirable Experience:

- Requires extensive, 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 of working knowledge in the biotech industry, with a specific understanding of QA operations an advantage as well as Regulatory agency engagement.
- Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
- Quality systems, pharmaceutical manufacturing, or laboratory processes, authoring and approving GMP documents

If this role is of interest to you, please apply now
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