Principal Scientist Microbiology

Careerwise Recruitment

Cork

PRINCIPAL SCIENTIST MICROBIOLOGY required by CareerWise Recruitment for our multinational pharmaceutical client in Co. Cork. The PRINCIPAL SCIENTIST MICROBIOLOGY position is within the Laboratory Operations Team will provide technical support and expertise to the QC Micro Laboratory & will provide QC Micro oversight on the Environmental Monitoring (EM) Program for the site. THE ROLE: * Provides to the site and network, expertise in QC Microbiology, in particular knowledge of developing & implementing a flexible and sustainable EM program. * Uses knowledge to improve the EM program, provide continuous improvement and execute tasks. * Handling of non-conforming EM/PM results. * Understands and coaches the importance of practical interpretation of QC Micro results /trends, their potential impact on process's/systems and suggested resolutions to same. * Has a good working knowledge of Analytical Microbiology Requirements and Systems. * Responsible for the preparation, review and approval of relevant technical documentation, risk assessments, CAPA's etc. * Troubleshooting of suspected Microbiological Contamination incidents. * Acts as a resource to colleagues with less experience in areas of QC Microbiology/EM. * Leads QC Micro project improvement teams. * Provides aseptic guidance on facility and process-related controls and changes as required. * Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes. * Interprets customer needs, assesses requirements and identifies solutions to non-standard requests. * Makes decisions within guidelines and policies which impact projects and QC Micro. * Liaises with the global QC Micro Community of Practice CoP to ensure alignment on actions related to the relevant Quality bulletin/QMS. * Champion the highest Quality and Compliance standards for the site. REQUIREMENTS: * Degree in Science (strong emphasis on Microbiology preferable. * Demonstrated change management skills (CEM) with continuous improvement. * At least 5 years' experience in the Pharmaceutical industry or a similar operating environment which includes a minimum of 2 years' experience in a QC Micro/Quality/Technical function. * QC Micro SME knowledge, knowledge from both operation and educational experience, is required. * Demonstrated use of Leadership Behaviours. * Knowledge and experience in interpreting current applicable regulatory requirements and providing independent support to the site. * Demonstrated ability to work independently and fully realize improvement initiatives with minimal guidance. * Demonstrated successes in a team environment, such as project teams, Six Sigma team etc. * Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels. * Highly motivated and interested in bringing current microbiology research and technology platforms toward a biopharmaceutical operations application. Please call Conor Twomey today for further information on 021-4297422 or email: ctwomey@careerwise.ie. CareerWise Recruitment (In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.

2273 days ago