Senior Analytical Chemist

Reporting to: Quality Manager

EXPERIENCE / QUALIFICATIONS

  • Must have a minimum of Three years industrial experience in a GMP regulated QC chemistry laboratory.
  • A degree in Analytical Chemistry, Pharmaceutical Chemistry or other related qualification is required.

    DUTIES & RESPONSIBILITIES

  • Ensuring that all operations within the chemistry laboratory are performed in accordance with applicable regulations, standards and guidelines.
  • Selection, installation, qualification and ongoing maintenance of laboratory equipment in accordance with the CLS laboratory quality system and GMP.
  • Generation of documentation to support test method transfers from clients.
  • Execution of testing as per approved protocols and test method etc.
  • Write up of all test results as per GMP and in accordance with the Quality System including Out of Specification results and Laboratory Deviations.
  • Review and approval of Laboratory quality records as per GMP and in accordance with the Quality System e.g. Out of specification results, laboratory deviations etc.
  • Training of junior staff.
  • Participation in self inspections audits.
  • Communicate with customers in relation to technical queries, forecasting etc.
  • GMP review of Laboratory log books.
  • Participate in Laboratory audits e.g. Regulatory Customer.
  • Interpret analytical results and resolve technical and/or operational problems and provide technical advice and support to all technicians/analysts.
  • Prepare, review and revise, as required, SOPs and specifications. Initiate and review out of specification and deviation reports, protocols and other appropriate documentation for proper functioning of the lab operation.
  • Support and manage projects to be on time, within budget and to meet business requirements.
  • Ensure the validation status for all test methods and laboratory equipment is compliant with regulatory requirements and internal procedures.

APPLICATION

Please email your application letter and C.V. to Miriam Murphy: mmurphy@cls.ie