Head Microbiologist

Collins Mcnicholas Recruitment

Waterford

Are you interested in joining a fast-growing and dynamic organization? If you are looking to progress your career with a top leader in the industry then I have an exciting opportunity for a Head Microbiologist. The individual will be responsible for maintaining and managing the QC Lab and mentoring and training junior analysts. If you have previous experience in a med device or pharma industry and have experience in using techniques such as bioburden analysis, water analysis, environmental monitoring, endotoxin, etc then please contact Aisling on 021-4320675 or email aisling.lane@collinsmcnicholas.ie for more information. Role Responsibilities: Management of personnel regarding reviews, time management, development, training and qualification. Schedule resources and activities to meet timelines. Ensure compliance to cGMP, safety and policies. Manage reports required for compliance activities and effective management of labs, e.g. monthly reports, development protocols/reports, validation reports etc. Management of laboratory equipment including, Qualification, e.g. IQ/OQ, calibration and maintenance. Administer and manage investigations as required e.g. deviations, alarms, 00S etc. Review and access results and develop appropriate action strategies. Set targets and objectives for the effective microbiological control of facility. Carry out all activities in compliance with company Safety & Environmental Standard Operating Procedures. Observe the safety rules and personal protective equipment requirements of all areas entered. Participate in team-based project work and plant-wide initiatives to improve the GMP compliance and financial performance. Manage & develop Quality Control systems. Approve procedures for the Quality control activities such as SOPs, specifications, test methods, calibration assessments etc. Maintain, develop and manage QC microbiology laboratory to cGMPs. Ensuring all follow Standard Operating Procedures while carrying out duties at all times. Participate fully in all GMP and operational training programs and complete all Training Records in an accurate and timely manner. Management of personnel assigned to QC Microbiology Laboratory. Role Requirements: Degree level Qualification. A min of 5 years' experience in a regulated medical device or pharmaceutical environment. Experience in Microbiological techniques such as: bioburden analysis, water analysis, environmental monitoring, endotoxin, sterility, media quality control and identification. Experience in Method validation and method transfer. Experience of scientific report writing including such documents as SOP's, protocols, deviations, reports etc. Familiarity and understanding of pharmacopeia requirements for pharmaceuticals. Familiarity and understanding of FDA and EU requirements for finished pharmaceuticals. For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email aisling.lane@collinsmcnicholas.ie. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs! This job originally appeared on RecruitIreland.com.

1716 days ago