Quality Engineer Microbiology

ICDS Recruitment

Galway

Quality Engineer Microbiology- Galway. Key Purpose. Our Client is looking for the Ideal candidate to fill a Quality Engineer role (microbiologist) and will primarily be responsible for ensuring compliance to all relevant regulations for sterilisation and microbiology which includes the maintaining all quality systems and related documentation. Key Responsibilities. Employees are expected to support the quality concepts inherent in the business including a variety of job related tasks which may not be specific to this position profile. Duties include: The Quality Engineer (microbiologist) is responsible for: The co-ordination and control of sterilisation, biocompatibility (finished product and raw materials) and environmental monitoring (including all cleanrooms. Responsible for the training of the quality inspectors in relation to sterile release and for overseeing this approval. Playing a role in the plant annual objectives. Ensure continued compliance with all Regulatory Standards. Monitor all aspects of product and paperwork preparation for sterilisation. Areas for improvement to senior management. Conduct training in sterilisation and microbiological and related procedures as required. Assist the principal quality engineer with the validation for sterilisation, as require. Interacting and presenting sterilisation and microbiological documentation during FDA, NSAI, Corporate and customer audits. Carry out a documented monthly evaluation of cleanrooms. Support any CAPA meetings related to sterilisation and /or environmental monitoring. Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner. Sterilisation and cleanroom Validations. Product adoptions to the sterile cycle. Engineering Change Order (ECO. Request for Corrective Action (CAPA. Material Review Request (MRR) – must countersign all related to sterilisation and environmental monitoring. Internal Audits. Failure Mode Effect Analysis (FMEA. Variation Permits (VP. Project meeting attendance as required. Attend and participate in daily cell meetings. Preparation of information for PMR and Management Review meetings. Work efficiently using own initiative, escalating decisions to the Quality Engineering Supervisor. Skills and Knowledge. Ability to communicate and work with people inside and outside the department. Good communicator (written and oral. Ability to train and lead where required. Ability to co-ordinate, plan and organise in a timely manner. Knowledge of engineering theories and methods. Rigorous attention to detail. Ability to work independently and without direct supervision. Qualifications and Person specifications. Ideally 3 – 5 years experience in similar position. Engineering or science Degree. Qualification in microbiology is essential. A Six Sigma qualification will be a distinct advantage. This job originally appeared on RecruitIreland.com.

1834 days ago