QC Micro Manager

Recruitment by Aphex; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Recruitment by Aphex is seeking an experienced Manager QC Microbiology to lead readiness activities for the expansion of our manufacturing site in Ireland. You will coordinate with QC, Quality, Manufacturing and Engineering to plan microbiology capabilities, processes, and systems for future operations.

The role emphasizes Right First Time, compliance and continuous improvement within a cGMP environment. The candidate will oversee planning, training, qualification, and potential transition of

Qualifications

• Leadership experience in QC or GMP environments.
• Strong cross-functional collaboration and communication skills.
• Experience planning and coordinating QC readiness activities.
• Knowledge of GMP documentation and QA processes.

Responsibilities

• Lead QC Microbiology readiness activities for site expansion.
• Coordinate microbiology readiness with QC, Quality, Manufacturing and Eng. teams.
• Develop and review GMP documentation and protocols for QC Microbiology.
• Plan procurement and qualification of microbiology lab equipment and consumables.
• Coach and supervise QC Microbiology personnel as needed.
• Ensure microbiology activities comply with GMP and regulatory requirements.
• Support environmental monitoring and microbiology testing programs.
• Contribute to continuous improvement and project delivery across functions.

Skills

Leadership

Cross-functional collaboration

Project planning

Quality systems

Education

Bachelor's degree in a Science-related field

Job description

Purpose

The role will primarily operate on a days-based working pattern, with flexibility to transition to or support a 16/5 working pattern depending on business and operational needs. The successful candidate will play a key role in supporting QC Microbiology readiness activities associated with the expansion of manufacturing operations at the site. The role will have a particular focus on establishing the people, processes, systems and laboratory capabilities required to support future operations. The Manager QC Microbiology will work closely with QC, Quality, Manufacturing, Engineering and other cross-functional partners to ensure that microbiology requirements are appropriately planned, developed and implemented as the site expansion progresses. In addition to project and readiness activities, the role will support the wider QC Microbiology organisation and may assume responsibility for operational teams and activities as business needs evolve.

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.

Qualifications/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, is preferred.
• The successful candidate should have experience working within a regulated cGMP manufacturing and/or testing environment.
• Experience in one or more of the following areas would be particularly advantageous:
  • Environmental Monitoring and microbiological control programmes.
  • Aseptic manufacturing operations
  • Establishment or expansion of QC laboratory or manufacturing capabilities.
  • Commissioning, qualification or validation activities.
  • Implementation of new microbiological equipment, methods or processes.
  • Development and implementation of GMP procedures and documentation.
  • Training and qualification of laboratory personnel.
  • Cross-functional project delivery.