QC Specialist Analytical Transfer

  • Nationwide
  • Temporary 11 months
  • JO-1701-62076_1483532026

Summary

Job Purpose:

  • Lead the validation/qualification and transfer of new methods as required supporting the introduction of new products to the site.
  • Co-ordinate the introduction of new products within Quality.
  • Project management of all quality activities required for the introduction of new products.
  • Report internally and to external contract sites, other ites as required.

Responsibilities

  • Support all activities involved for the transfer, validation and qualification of test methods and processes.
  • Write/review and approve analytical gap assessments, protocols, reports for validation/transfer activities.
  • Support statistical approach to setting of acceptance criteria for validation/transfer.
  • Support Annual Product Quality Review for validation.
  • Support regulatory filing submissions for new products.
  • Assist in the preparation and review of area documentation e.g. SOP's and Forms
  • Support statistical approach to setting of acceptance criteria for validation/transfer.
  • Support the project management for the introduction of new products.
  • Write/review technical transfer deviations.
  • Troubleshoot laboratory methods and instrument problems.
  • Liaise with all customers both internal and external.
  • Facilitate training of analysts on new technologies.
  • Report project updates to the QC lead.
  • Perform and assist in additional duties as directed by the QC Lead
  • Support Laboratory inspection and audits


Requirements

  • B.Sc. degree in chemical sciences, or other related technical degree or equivalent experience in regulated industry.
  • 5+ years working within quality control environment, with a minimum of 2 years on analytical validations and transfers.
  • Experience with technical elements of the analytical method validation and transfer process.
  • Experience with Lab systems an advantage. (LIMS, CDAS, QTS, PDOCs).
  • Proven success in proactive project management.
  • Experience is managing multiple projects and reporting regularly to management and senior management within the organisation.
  • Proven expertise and technical competence.
  • Proven ability to communicate problems and required resolution in a positive and proactive manner.
  • Proven ability to recognise problems with equipment, methods, software, procedures and resolve the issues.
  • Self-directed, self-motivated with a demonstrated record in project accountability.
  • Proven knowledge in analytical techniques, analytical instrumentation theory and practice.
  • Excellent communications skills


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