Collins McNicholas

Are you interested in joining a fast-growing and dynamic organization?

If you are looking to progress your career with a top leader in the industry then I have an exciting opportunity for a Head Microbiologist 

The individual will be responsible for maintaining and managing the QC Lab and mentoring and training junior analysts. If you have previous experience in a med device or pharma industry and have experience in using techniques such as bioburden analysis, water analysis, environmental monitoring, endotoxin, etc then please contact Aisling on 021-4320675 or email aisling.lane@collinsmcnicholas.ie for more information 

Role Responsibilities:

  • Management of personnel regarding reviews, time management, development, training and qualification.
  • Schedule resources and activities to meet timelines
  • Ensure compliance to cGMP, safety and policies.
  • Manage reports required for compliance activities and effective management of labs, e.g. monthly reports, development protocols/reports, validation reports etc.
  • Management of laboratory equipment including, Qualification, e.g. IQ/OQ, calibration and maintenance.
  • Administer and manage investigations as required e.g. deviations, alarms, 00S etc.
  • Review and access results and develop appropriate action strategies
  • Set targets and objectives for the effective microbiological control of facility
  • Carry out all activities in compliance with company Safety & Environmental Standard Operating Procedures.
  • Observe the safety rules and personal protective equipment requirements of all areas entered
  • Participate in team-based project work and plant-wide initiatives to improve the GMP compliance and financial performance.
  • Manage & develop Quality Control systems
  • Approve procedures for the Quality control activities such as SOPs, specifications, test methods, calibration assessments etc.
  • Maintain, develop and manage QC microbiology laboratory to cGMPs
  • Ensuring all follow Standard Operating Procedures while carrying out duties at all times.
  • Participate fully in all GMP and operational training programs and complete all Training Records in an accurate and timely manner.
  • Management of personnel assigned to QC Microbiology Laboratory.

 

Role Requirements:

  • Degree level Qualification
  • A min of 5 years’ experience in a regulated medical device or pharmaceutical environment
  • Experience in Microbiological techniques such as: bioburden analysis, water analysis, environmental monitoring, endotoxin, sterility, media quality control and identification
  • Experience in Method validation and method transfer
  • Experience of scientific report writing including such documents as SOP’s, protocols, deviations, reports etc.
  • Familiarity and understanding of pharmacopeia requirements for pharmaceuticals
  • Familiarity and understanding of FDA and EU requirements for finished pharmaceuticals

For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email aisling.lane@collinsmcnicholas.ie

 

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