Job Type: Perm
Job ID: JO-1908-19279
Consultant: Karen McHugh
Do you have 4+ years of experience working in Microbiology in the pharmaceutical industry?
Do you have experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
Senior Microbiology Analyst- Cell Therapy - Dublin West - Dublin
JobContax is a preferred supplier to one of the world's leading BioPharma companies.
With major capital investment happening in their Irish plants, this is an exciting time to join the team
Responsible for oversight of the Microbiology laboratory supporting the manufacture of Alofisel Cell therapy product.
Oversee aseptic practices (gowning, monitoring, cleaning and related training).
Perform microbiological testing as required to support operations.
Perform environmental monitoring as required to support operations.
Ensure that the Microbiology laboratory is set up and operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times.
Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global standards.
Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations.
Training of microbiology analysts
Scheduling of microbiologist work via visual management
Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
Oversee the Cell Therapy Manufacturing Facility environmental monitoring programme for the facility.
Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
Oversight of contract testing laboratories associated with microbiological testing
Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence.
Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
Manage an effective laboratory documentation system. Prepare and review documents as required.
Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer).
Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times.
As required, act as designee for the Plant Microbiologist in their absence.
Participate as required in global project teams relating to Microbiology and wider quality activities.
Participate fully in any cross functional training initiatives.
Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
Ensure timely completion of all SOP, reading, training and assessment.
More than 4 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company
Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management
Thorough knowledge of GMP and current FDA & EMEA regulations
Knowledge and experience of Lean Laboratories is preferable
Previous experience in setting up a new Microbiology laboratory is desirable
Excellent organizational, communication, interpersonal and report writing skills
Strong Microbiology knowledge, with the ability to act as a Subject Matter Expert
Ability to adapt to changing priorities
Excellent benefits package
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail firstname.lastname@example.org or phone +353-1-7978720
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