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 firstname.lastname@example.org for more information
- 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.
- 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 email@example.com