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Pharmaceutical Senior Bioassay Analyst

Job description

As a Senior Bioassay Analyst you will be responsible for planning and performing multiple, complex routine/ non-routine methods and procedures and a large variety of assays.

Your duties:

  • Plan and implement procedures and systems to maximise operating efficiency.
  • Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
  • The Senior Bioassay Analyst will lead training of staff on technical aspects of job as required.
  • You will develop, revise and implement procedures that comply with appropriate regulatory requirements.
  • Complete qualification of analytical equipment and related testing functions.
  • Participate in Analytical Method Transfers
  • Compliance with Standard Operating Procedures and Registered specifications.
  • Ensure the laboratory is operated in a safe manner
  • Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
  • Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.
  • Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
  • Participate in regulatory agency inspections as required.
  • Plan and implement procedures and systems to maximise operating efficiency.

Qualifications:

  • Have 2-3 years of experience in a pharmaceutical/healthcare Laboratory.
  • Experience in Bioassays, Immunoassays and Cell Culture is essential.
  • Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.
  • Experience with TrackWise, Change Control Systems, EDMQ and SAP an advantage
  • Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.

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