Collins McNicholas

Purpose

Provide supervision of the Microbiology Laboratory in Galway, to provide a quality, efficient and cost effective testing service to the Galway site. Ensure that the microbiology testing within the laboratory is carried out in line with all quality system and regulatory requirements. The supervisor shall provide support and guidance in the areas of cGMP, Compliance, Regulatory, technical investigations, test method validation and environmental control.

Responsibilities

  • Demonstrates commitment to the Quality Policy (patient safety and product quality) through the daily execution of sound quality practices and the maintenance of an effective quality system.
  • Responsible for maintaining a full understanding and complying with all the regulations governing the quality system.
  • Supervising and exercising functional control of the laboratory such that a compliant, cost effective and efficient service is provided.
  • Final review and approval of laboratory results, protocols, reports, SOPs etc.
  • Provide technical guidance/ trouble shooting in the event of equipment failure, NCEs or out of specification results.
  • Consult on quality and microbiological issues, support problem solving and resolution, and provide quality management advice and counsel to customers for related laboratory testing needs.
  • Represent the laboratory on cross functional project teams as required.
  • Liaise with various operational departments to ensure that the laboratory meets and exceeds the plants requirements.
  • Co-ordinate the Environmental Control testing (water/air & surface microbial/air particulate) of controlled areas within the plant according to documented procedures.
  • Support validation of new and existing products to ensure compliance with current microbiology regulatory standards.
  • Assists in the implementation of new tests, new technology, and improves existing tests.
  • Leads laboratory projects for continuous improvement within the laboratory.
  • Advises and directs laboratory Technicians and functions as a trainer/ troubleshooter when problems arise during testing.
  • Maintaining adequate instrumentation and lab facilities.
  • Maintaining safety awareness in the laboratory.
  • Training and development of laboratory staff. Ensures direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
  • Delivery of key Quality and Performance Objectives.
  • Selection and recruitment of analytical staff in conjunction with human resources.
  • Conduct performance reviews of direct report.

Qualifications and Experience:

  • HETAC Level 8 degree (240 credits) in Microbiology or similar discipline.
  • Minimum of 4 -6 years experience in a similar role.
  • Experience of managing a team is essential for this role.
  • Good technical capabilities, communication skills, teamwork abilities and initiative.

 

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