QC Microbiology Manager

Life Science Recruitment; Leinster; On-site; EUR 90,000 - 120,000; Full time

Job summary

Life Science Recruitment is seeking a QC Microbiology Manager for an award-winning pharmaceutical organisation in Dublin. The role focuses on building readiness for the site’s manufacturing expansion, establishing people, processes and systems for future operations.

The position involves cross-functional collaboration with QC, Quality, Manufacturing and Engineering, and offers day-based work with potential shifts as the project evolves.

Qualifications

• 6+ years of biopharmaceutical QC experience or GMP lab experience.
• Experience in environmental monitoring, aseptic manufacturing or QC lab start-up/expansion.
• Experience with GMP documentation and cross-functional projects.

Responsibilities

• Support QC Microbiology activities for site expansion and manufacturing readiness.
• Lead QC Microbiology readiness planning and execution ahead of operations.
• Develop and review GMP documentation (procedures, protocols, reports).
• Define and implement microbiology lab equipment, consumables and media.
• Plan resource, training and qualification for QC Microbiology personnel.
• Provide input in cross-functional project activities and forums.
• Ensure compliance with GMP, safety and regulatory standards.

Skills

Biopharmaceutical QC

GMP Compliance

Project Delivery

Education

Bachelor’s degree in a Science-related field

Job description

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

The QC Microbiology Manager will support QC Microbiology readiness for the site’s manufacturing expansion, focusing on establishing the people, processes, systems and laboratory capabilities required for future operations. Working cross-functionally with QC, Quality, Manufacturing and Engineering, the role will support project delivery and may take responsibility for operational teams as business needs evolve. Primarily day-based, with flexibility to support/transition to a 16/5 working pattern.

Key Responsibilities:

• Support the planning and implementation of QC Microbiology activities associated with the expansion of manufacturing operations at the site.
• Lead and coordinate QC Microbiology readiness activities, ensuring appropriate planning and execution in advance of operational requirements.
• Support the development, review and implementation of GMP documentation, including procedures, protocols, reports and other controlled documentation required to establish and maintain QC Microbiology operations.
• Support the definition, procurement, qualification and implementation of microbiology laboratory equipment, consumables and media required to support future operations.
• Support resource, training and qualification planning to ensure QC Microbiology personnel are appropriately prepared for future operational requirements.
• Provide microbiology input into cross-functional project activities and represent QC Microbiology at relevant project and operational forums.
• Work closely with Quality, Manufacturing, Engineering and other stakeholders to ensure microbiological requirements are incorporated into project and operational planning.
• Support the establishment, implementation and maintenance of Environmental Monitoring and other microbiological testing programmes, as applicable.
• Supervise and/or manage QC Microbiology personnel as required and provide effective coaching, development and technical leadership.
• Ensure QC Microbiology activities are performed in a safe manner and in accordance with applicable GMP requirements, procedures and registered specifications.
• Develop and maintain quality systems within the QC Microbiology function to ensure ongoing compliance and inspection readiness.
• Provide an effective and efficient QC Microbiology service to operations, with a strong focus on Right First Time (RFT), compliance and continuous improvement.
• Support the timely investigation and resolution of laboratory investigations, deviations, non-conformances and other quality events.
• Review microbiological and Environmental Monitoring data and identify trends and opportunities for further development or improvement.
• Keep abreast of current regulatory, corporate and industry requirements and compliance trends relating to microbiology, laboratory operations and aseptic manufacturing.
• Review and approve, as appropriate, SOPs, investigations, non-conformances, validation and qualification protocols and reports, microbiological trend data, method validation/verifications and equipment qualification documentation.
• Participate in regulatory agency inspections and internal audits as required.
• Plan and implement procedures and systems to maximise operating efficiency and support the successful transition of project activities into routine operations.
• Manage and contribute to departmental productivity, quality and compliance objectives.
• Support wider QC Microbiology operational activities as required, including the potential transition to a 16/5 working pattern depending on future business needs.

Education and Experience:

• Bachelor’s degree in a Science-related field is required.
• 6+ years of biopharmaceutical QC experience, or related Quality Control/GMP laboratory experience within the pharmaceutical or medical device industry
• Experience in one or more of the following would be advantageous: Environmental Monitoring/microbiological control, aseptic manufacturing, QC lab or manufacturing start-up/expansion, commissioning/qualification/validation, implementation of new microbiological equipment or methods, GMP procedure/documentation development, personnel training/qualification, and cross-functional project delivery.