LSC have a requirement for a QA Specialist to join a leading biotech company based in Cork. For more than 25 years this company has been a global leader in the field of biomedicines, in particular pioneering monoclonal antibody technology a cutting-edge approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
As a QA Specialist you will:
o Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
o Supports the management of GMP compliance systems through the following activities: Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
o Carries out tasks related to the administration of project and site nonconformance management systems:
o Reviews and/or approves nonconformance investigations and their associated documentation.
o Manages entry of nonconformance records into the appropriate electronic system.
o Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
As a QA Specialist you will need:
o Bachelors Degree in a scientific/technical discipline required
o A minimum of 2 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
o Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
o Desirable: Experience in statistical sampling plan development & experience in a biopharmaceutical or pharmaceutical plant startup.
Please contact Regina in LSC on 021 4777329 for further details on this role or apply directly through this advert.