Your new opportunity is for a greenfield start-up environment. With a focus on new products being brought into the plant and the company as a whole, this is a fantastic chance for you to get hands on experience from the ground up. You will be challanged and stimulated in this fast paced and dynamic role.
The purpose of the role is to oversee the general running of the Microbiology laboratory, Environmental Management and the aseptic technique associated with the manufacture of products onsite.
- Responsible for oversight of the Microbiology laboratory supporting the manufacture of products.
- 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 Company 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 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.
- Drive and promote the corporate values of Takeda-ism within the workplace.
- Actively foster, in cooperation with other TIL 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.
- Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
- Degree in Microbiology or other relevant field.
- 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
Interested in this role? Apply for this position to be considered.
Not sure if this is the right fit but want to see what other opportunties are available? Get in touch on 014744692 or alternatively email me at email@example.com