Collins McNicholas

Purpose

Responsible for ensuring that Raw Materials, Finished Goods, non-routine and Stability testing is carried out in accordance with cGMP laboratories. The supervisor shall provide support and guidance in the areas of cGMP, Compliance, Regulatory, Technical Investigation, test method optimization, test method validation and technical transfers in the laboratory.

Responsibilities

  • Primary Commitment to patient safety and product Quality.
  • Understands and comply with all the regulations governing the quality systems.
  • Delivery of key Quality and Performance Objectives.
  • Ensure compliance for both yourself and team to mandatory training requirements.
  • Supervising and exercising functional control of the laboratory such that a compliant, cost-effective and efficient service is provided.
  • Maintaining adequate instrumentation and lab facilities.
  • Maintaining safety awareness in the laboratory.
  • Training and development of laboratory staff.
  • Overseeing the analysis of the finished product, in-process, R&D, validation samples and Stability Samples.
  • Supervision of method validation and analytical technical transfers from donor sites.
  • Final review and approval of laboratory results, protocols, reports SOPn++s, etc.
  • Provide technical guidance/ troubleshooting in the event of equipment failure, deviations or out of specification results.
  • Selection and recruitment of analytical staff in conjunction with human resources.
  • Conduct performance reviews of direct report.
  • Represent the laboratory on cross-functional project teams as required.
  • Attend and represent the Analytical Laboratory at various meetings as required and communicate the required information as required.
  • Liaise with various operational departments to ensure that the laboratory meets and exceeds the plant’s requirements.
  • Drive continuous improvement within the laboratory in terms of Quality, Compliance and Efficiency using tools such as LEAN and Six Sigma.
  • Ensures all 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.

Qualifications

  • HETAC Level 8 in relevant field with minimum 6-8 years experience in a similar role.
  • Good technical capabilities, communication skills, teamwork abilities and initiative.
  • Strong leadership and influencing skills required.

For confidential discussion on the role and company call Chris O Toole now on 091 706 713 or send your CV to christopher.otoole@collinsmcnicholas.ie

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