They are entering an exciting period of growth and moving from R&D to clinical development and manufacturing. The individual must therefore be seeking a challenging, evolving and changing role. The position will initially be laboratory based but for the right candidate will offer job progression which could encompass elements of project and staff planning and management.
My client is currently moving to a new cGMP facility in Deeside and this role will be located in the new facility. On offer is a competitive salary and Pension.
As a Senior Microbiologist you will:
· Ensure that analytical testing is performed and reported on all raw materials, intermediates and finished products following requirements
· Coordinate, support training and lead the sampling and testing of raw materials to ensure sampling operations are performed and reported in accordance to regulatory/industry standards
· Initiate, manage and track the progress of deviations within own area to ensure that they are closed within the required timelines and to agreed standards
· Maintain all stock of media and consumables to ensure continuous testing capability within budgetary constraints.
· Manage the day to day activities of the laboratory
· Draft and review laboratory protocols and reports, validation studies and project work
· Maintain and improve knowledge of analytical techniques and contribute to providing new and improved methods of working or equipment and to provide trouble shooting and problem solving to resolve issues in a timely manner
· Liaise with maintenance staff and suppliers to ensure laboratory equipment and services are maintained to a high standard and in good working order
· Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures
· Assist QA in the performance of internal and external audits as required
· Ensure the compliance of all laboratory procedures and personnel with all Health & Safety Guidelines, with particular reference to COSHH and Biological Safety Regulations and Health & Safety at Work Act 1974
· Contribute to team building, training and problem-solving initiatives internally and cross site
· Represent QC on project teams and in meetings to provide subject matter expert analytical/ bioassay knowledge
The successful Senior Microbiologist will have the following qualifications, skills and experiences:
- BSc degree in Biological/Biochemical Sciences, Chemistry, Engineering or related discipline with good practical lab experience
· Experience in a microbiological testing laboratory and experience of working in a pharmaceutical controlled environment
· Essential knowledge in the areas of Environmental monitoring, Bioburden testing, Endotoxin testing, qualification and validation of microbiological methods
· Good understanding and application of cGMP and regulatory requirements
· Excellent communication alongside with close attention to detail
· Be a team member and proven management and leadership skills
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH41438 in all correspondence.
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