QC Manager

  • Contract
  • Cork

Website Ref:TPM04651

Summary:
Our client is a biologics company based in cork, looking for a QC Manager who will manage a project team looking after the planning, execution and roll out of new Microbiological Methods and Technologies, and Optimisation and Improvement of existing methods. Delivering on key Business projects – Introduction of Sterility test lab and Isolator System and supporting introduction of New Drug Prod Site Microbiologist, responsible for providing technical leadership relative to the validation, optimization, development, troubleshooting of all aspects of Microbiology throughout the facility.

Responsibilities:

  • Reviewing routine testing results, preparing protocols and reports, performing OOT and deviation investigations, providing cGMP and technical development for staff, and interfacing with other internal and partner departments relative to quality issues.
  • Provides technical leadership and establishes appropriate systems to ensure departmental compliance with regulatory requirements.
  • Coordinate effective planning and execution of projects related to Microbiological methods/ Technology.
  • Ensure timelines are managed effectively.
  • Ensure consistent delivery to stakeholders and effective communications.
  • Provide Technical expertise to QC and external teams.
  • Assist in trouble shooting and optimisation of methods.
  • Coach and develop individuals within the team.
  • Responsible for overall performance of the team in areas of technical delivery and inter-team and inter-department collaboration.
  • Collaboration with QC leads to ensure the overall running of the QC Laboratory.
  • Review and approve documents such as standard operating procedures, protocols, reports and track-wise documents.
  • Ensure the team is compliant to GXP and safety and environmental standards.
  • Conduct and document out of specification / out of trend result investigations.
  • Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
  • Lead and implement initiatives that add value to the QC and site operations.
  • Deliver on capital/budget.
  • Scope out future efficiencies/ optimization opportunities.
  • Provide technical expertise and leadership to the QC, QA Val. department and across site, MFG, Engineering, Projects.
  • Provide leadership within Quality ensuring quality culture, goals & objectives are achieved.
  • Establishment of Environmental Monitoring Program sample locations on site and support ongoing review of environmental data and trend results.
  • During development and expansion of the facility, plan for and lead in collaboration with project and support functions the set up and qualification of clean utilities, environmental monitoring programs and where necessary sterilizing equipment.
  • Contamination Control Strategy.
  • Act as a Subject Matter Expert in Deviations, Change Controls and in Regulatory Inspections as necessary.
  • Review and approval of Sterilisation, Sanitisation, Cleaning reports.
  • Key contributor of out-of-specification/out-of-trend result investigations.
    Interface with other departments (Regulatory Affairs, Quality Assurance, Facilities, etc.) and contractors as necessary.
  • Interpret and apply applicable Annex 1, Annex 2, 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives.

Qualifications & Experience:

  • Scientific Degree is a minimum requirement. Masters degree would be an advantage.
  • 8 years’ + previous experience in a similar role in a GMP environment.
  • Previous people management experience is essential for the role.
  • The position requires thorough knowledge and experience with Microbiology, Environmental Monitoring and Regulatory Guidelines
    Excellent organizational and project management skills.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.