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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