New Sterility Assurance Microbiologist

CPL

Dublin South

On behalf of my client, a Dublin based pharmaceutical company, I am rcruiting for a Sterility Assurance Microbiologist. The successful candidate will be responsible for the following: Responsible for development, management and trending Environmental Monitoring (EM) program; Provide coaching to other functions/sites in using problem solving structured approach; Support and lead risk reduction and continuous improvement initiatives in line with company strategy; Support and lead problem solving investigations for product and process deviations or customer complaints; Responsible for deviations investigation and documentation associated with Corrective and Preventive Actions; Proactively identify and escalate opportunities for risk reduction and Continuous Improvement; Act as Change Leader for key projects; Oversight of microbiology laboratory in routine and non-routine product testing and environmental microbiological testing. Perform microbiological validations as needed for products and processes. Ensure products and processes comply with procedures and the principles of GMP. Support and assist in internal and external audit program. Participation in regulatory and corporate / internal audits and performance of supplier audits(as required), including documentation review. Conduct training of Quality and Manufacturing personnel. Development of quality system procedures, controlled documents and processes. Risk Management of the quality system and processes. Support facility projects including process development and quality improvement initiatives. Applications are invited from candidates with the following background and experience: Degree in Science with a speciality in Microbiology. Post qualification experience of at least 5 years. Previous experience in an aseptic manufacturing facility. Working in a project based environment. Have experience in the use of quality improvement and problem solving tools (Failure Modes & Effects Analysis (F.M.E.A.), Capability Studies, Process Mapping, DMAIC, PDCA, etc…), and the interpretation of data. Have experience of critical equipment and process Change Control. Have experience in microbiology and associated validations and processes. For a full Job Spec and to apply for this role please call Deirdre on +353 1 2784671 or e-mail dbolger@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com. This job originally appeared on RecruitIreland.com.

2495 days ago