QA Specialist

Life Science Consultants Ltd

Cork

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. The role is primarily focused on providing daily support for attending project meetings (process/EHS reviews, pre start-up safety reviews etc.) throughout the project lifecycle. As a QA Specialist you will: o Batch Record Review & material release to ensure compliance with GMP requirements. o Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints. o Carries out tasks related to the management of batch records design and approval. o Carries out administration of the SAP Quality Management Module. o Carries out tasks relating to the management of site change control systems. o Compiles Annual Product Reviews. o Supports all validation activities on site as described in the Site Validation Master Plan. o Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.). o Supports system qualification and process validation activities. o Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance. As a QA Specialist you will need: o Bachelors Degree in a scientific/technical discipline required. o A minimum of 3-5 years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry. o Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. o DESIRABLE: Experience in auditing of external suppliers, contractors and vendors. Please contact Amparo in LSC on 021 4777329 for further details on this role or apply directly through this advert. This job originally appeared on RecruitIreland.com.

2399 days ago