The purpose of this role is to lead the microbiology and stability activities within the QC team thereby ensuring that internal and external customer requirements are met. The QC lab leader (Micro and Stability) will also participate in identifying resource requirements (personnel, equipment and facilities) for the QC group, participate in the recruitment of personnel for the laboratories and develop the strengths/talent of team members and ensure that group and individual training requirements are met.
The Cork site is welcoming exciting growth and new expansions to support much-needed capacity.
Duties and Responsibilities:
- Responsible for Microbiologists & stability chemists within the QC department.
- Oversee the Microbiology lab, ensure the testing requirements are met and the lab is maintained to an inspection ready standard
- Oversee the stability program and provide support to internal and external customers.
- Collaborate closely with other teams on site to plan and coordinate testing and disposition activities for the QC laboratory.
- Provide support to the Stability Chemist for management of Stability program and ensure that Stability testing is carried out within the permitted timelines.
- Carry out a review of Stability data for regulatory submissions and Annual reports as the need arises.
- Provide support for the microbiologists on testing, ensuring the agreed plan can be achieved
- Generate, Review and Approval of change controls, CAPA’s, deviations etc, as required
- Review and approval of GMP documentation e.g. equipment qualification, procedures, protocols/reports etc
- Carry out monthly review of Laboratory Investigation Reports for the labs
- Provide support for engineering and production on all microbiology issues are required.
- Generate reports, metrics and other documentation to support the lab program.
- Communicate any outstanding quality issues to the QC manager as appropriate.
- Prepare and support Quality group for internal and external audits
- Be flexible and willing to adapt to business needs in a fast pace and changing CDMO environment, serving multiple customers.
- BSc Hons Degree Science, and/or higher degree.
- Knowledge of and participation in inspections, audits and reviews of operations and processes is required.
- Knowledge of lab systems
- Detailed knowledge of the cGMP requirements relevant to the role and understand the GQMPs and GQPs that relate to the role.
- GMP competent as applied to the laboratory environment
- Relevant experience within the pharmaceutical industry.
For a confidential discussion and more information on the role, please contact Rory Walsh.