Are you a Quality Assurance Specialist with expertise in upstream technical processes? Then LSC have an exciting role that would be right for you. Our multinational biotech client based in Dublin is looking for an experienced Quality Assurance Specialist to join and support their dynamic biotech design team of specialists.
As a Quality Assurance Specialist you will:
o Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for biologics facility.
o Review and approval technical support documentation. (Examples include cleaning, process, method validation).
o Review and approval of manufacturing batch records.
o Provide quality support for implementation of new product on SAP.
o Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained /controlled.
o Provide QA support for risk based verification activities. Review and approval equipment/utilities verification documentation from design to post execution
As a Quality Assurance Specialist you will have:
o B.Sc. in science/engineering with a minimum of 4 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
o Min 4 years QA experience in a pharmaceutical manufacturing environment
o Previous experience with MES.
o Experience with Batch Records, CAPA, CGMP, Documentation and Method Validation
If you wish to discuss this position, please call Mairead on 021-4777329 or apply directly.