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QC Manager-chemistry (LOA007664 )

Limerick, Country: Ireland
Job Type:
Job Description
Location: Limerick
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
May be suitable for: Quality Control Manager
Summary:The successful candidate will be responsible for development, implementation and management of the QC Chemistry department for a cGMP biopharmaceutical manufacturing facility.

Essential Duties and Responsibilities include, but are not limited to, the following:
  • Lead and coordinate the startup of a new laboratory building including ensuring monitoring and communicating timeline.
  • Ensure construction adherence to plan.
  • Lead a team of six or more individuals to order equipment and supplies to facilitate occupation of the new QC Laboratory.
  • Train on new analytical methods and ensure the successful transfer to the new laboratory.
  • Oversee QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness.
  • Track and coordinate major analytical investigation and method improvement.
  • Track and monitor timeline of analytical validation projects.
  • Monitor the departmental performance for NOE/EOE/DNF/CAPA/WF/OJT, track, assist and organize continuous improvement event.
  • Coordinates with members of Manufacturing, R & D, and Formulation to provide analytical support.
  • Interact with Regulatory Agencies as needed to ensure cGMP compliance.
  • Supervises QC Analysts, distributes work load, and monitors progress.
  • Special projects as assigned.

Education and Experience:
  • BS in chemistry, biology or related field with 7+ years’ experience in laboratory management and analytical sciences and 5+ years’ experience in a supervisory/leadership capacity.
  • Thorough understanding of Analytical Testing in a cGMP environment for Raw Materials, Wet Chemistry, and HPLC assays
Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company size: 1-49
Contact: NA