Job Title: QC Microbiology Supervisor
Role Type: Permanent
Location: Galway

Force Recruitment have partnered with a leading Pharmaceutical Manufacturer in Galway to hire a QC Microbiology Supervisor on a full time, permanent basis. This role reports to the Microbiology Lab Manager and join a strong Microbiology team. The role is responsible for overseeing microbiological testing,  method validation,  environmental monitoring  and contamination control in compliance for the site.
Previous people management experience is derisible, however please apply if you have strong Microbiology experience and are interested in taking a step into people management.

Duties & Responsibilities

• Co-ordinate and supervise all microbiological testing within the Microbiology Lab

• Review and approve batch release documentation, raw material and stability data.

• Provide guidance, coaching and expertise to the Microbiology team establishing employee goals and objectives and maximizing development opportunities.

• Co-ordinate and supervise Microbiology Laboratory Investigations. 

• Ensure highest quality standards are maintained in areas of responsibility and that industry best practice is adopted in accordance with current GMP, GLP and regulatory directives.

• Responsible for the co-ordination of the Microbiology Department SOP updates, change controls, deviations, investigations and trend reports.

• Scheduling of instrument calibrations and maintenance.

• Ensure validity of all test methods in the laboratory are established and documented.

• Act as Designee/Deputy for Microbiology Lab Manager.

• Manage and review the environmental monitoring program to ensure aseptic conditions in the manufacturing areas.

• Investigate environmental monitoring out of specification results, determine root cause and implement corrective actions.

• Oversee the scheduling of the Aseptic process simulations and support the review and approval of the reports.

• Participate in the implementation and maintenance of a comprehensive contamination control strategy for the sterile manufacturing processes.

• Track and report quality system metrics relevant to testing and investigations

• Participate in internal and external audits, support the provision of responses for any microbiology citations and represent the microbiology department in audit discussions relating to environmental monitoring and contamination control.                                          

Qualifications & Experience Required:

• BSc Level 8 degree Bachelor's degree

• 6+ years experience in a Microbiology role, within the Pharmaceutical or Medical Device industry

• Previous experience with Contamination Control Strategies, Risk Assessments and Sterility Assurance would be extremely beneficial.

• People management experience is desirable but no essential.

• Knowledge of Annex I and US and EMA GMP regulations.

• Ability to work cross functionally with other departments (Analytical, Quality, Manufacturing and Regulatory).

• Proficient computer skills (Excel, Word, PowerPoint, databases, Microsoft project planning (or similar software).

We are hoping to connect with and speak to candidates with varying levels of QC Microbiology experience, so please apply if you’re interested in moving roles, and hearing about other potential opportunities.