Operations Shift Specialist
- Ireland, Dublin
- Contract
- Life Sciences
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.
- 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
#LI-CH3
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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