Cache of job #13767019

Job Title

Sr. Quality Specialist

Employer

Life Science Consultants Ltd

Location

Cork

Description

LSC are currently looking for Senior Quality Specialist to work on a Biopharmacuetical Project in Cork to provide Quality leadership, oversight and direction to the development, implementation and execution of process validation and technical transfer project activity. The Senior Quality Specialist - Quality Support will fulfil the quality signatory role for cGMP requirements. Primary activities/responsibilities: o Review and approval of equipment, computer system and laboratory analytical qualification activities (IQ, OQ. o Review and approval of system support and process validation activities (e.g. steam/dry heat sterilisation/SIP processes/ Analytical and Micro methods. o Providing Quality insight and direction on the planning and execution of engineering, process support projects (e.g. equipment/support process upgrades/ automation/ aseptic process improvements/ WFI improvements ) o Provide Quality insight and direction on planning and execution of new product introduction and technical transfer. o Provide consultation, Quality oversight and expertise for computer systems projects. The Senior Quality Specialist - Quality Support must be able to translate the regulations (e.g. 21 CFR Part 11), MSD company policies (e.g. MSD SDLC) and regulatory terms and intent into language that is understandable to the customer/system owner. o Change control impact assessment and approval. You will have: o Degree or 3rd level qualification (Science, Quality. o Desirable evidence of Continuous Professional Development. o A minimum of five years system validation / Quality engineer experience in biotechnology, pharmaceutical or medical device industry. o Experience in manufacturing / laboratory equipment and process validation. o Experience working as part of a large, multi-disciplinary team completing full project lifecycle implementations. o Knowledge and experience in interpreting current regulatory requirements and providing independent support to a manufacturing operation. For full details on this role please contact Kathy in LSC on 021 4777329 or apply directly through this advert. This job originally appeared on RecruitIreland.com.

Date Added

2468 days ago

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