Our client, a global pharmaceutical organisation are currently recruiting for a Laboratory Coordinator to join their organisation. This role will sit with the Quality Systems Group and report directly into the Quality Systems Manager.
• Assist in delivering on key objectives in relation to Method Transfers between in-network and 3rd party laboratories in line with GMP, GLP and safety requirements.
• Provide technical support and troubleshooting as required for in-network and 3rd party laboratories
• Coordinate and manage stability placement with 3rd party labs
• Manage the review of stability data within the Regional team
• Schedule, coordinate and report on Product Launch Method transfers
• Coordinate projects related to Laboratory requirements on behalf of EMEA region, as required.
• Manage laboratory investigations and completion of reports within the required timelines
• Review and approval of AMT reports for EMEA region
• Highlight any discrepancies, deviations or non-conformance’s in testing or work practice which may impact on achieving project deadlines or customer delivery
• Review testing schedules with the release teams to meet dispatch requirements.
• Provide technical support to in-network and 3rd party Laboratories
• Have an overview of all relevant projects ongoing within the Quality department relating to Contract and 3rd Party testing of products
• Adhere to and maintain the quality systems relating to 3rd party testing
• Approve and investigate analytical issues/deviation reports and change controls as required
• Escalate stability OOS results through the escalation system
• Maintain a state of audit readiness for in-network/3rd party systems
• Ensure that the systems with a GMP impact are maintained as per written procedures
• Minimum of a Bachelor Degree in Science or related pharmaceutical discipline
• At least 5 years pharmaceutical Quality experience is desirable, ideally within a QC environment
• Excellent interpersonal skills
• Experience in a high volume environment
• Track record with the HPRA/FDA is desirable
• A proven identifiable track record of success in a similar environment
• Experience in managing change and seeking continuous improvements
• Good Computer skills are required
If you would like further Information you can contact the recruiter directly:
Sinead Cullen | Tel: +353 (0) 1 507 9252