Quality & Laboratory

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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