My key client is currently under a massive expansion and is growing their current presence in Ireland. They are looking for an experienced QC Manager to the API and oral solid dosage and Biologics Quality Control laboratories in Grange Castle. Testing requirements will include raw materials, in-process, intermediates, APIs, finished drug product, validation samples, stability samples and cleaning samples. Management of analytical method transfer activities will also be required to be involved in a greenfield project.
This is an excellent opportunity to be part of something from scratch and you will be responsible for leading commissioning and qualification activities.
- Responsible for the overall management of two separate Quality Control laboratories supporting the manufacture of API and finished capsule and biologic product. The API QC laboratory operates on 24/7 shift.
- Ensure that QC laboratories are set up and operate in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times. Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and standards.
- Develop and maintain excellent communication and collaboration between QC and other work areas.
- Supervise QC Executives including training, recruitment, motivation, discipline and performance appraisal.
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of the following: raw materials, packaging components, in-process samples, intermediates, APIs, finished drug products, validation samples, stability, purified water and cleaning samples.
- Lead and participate in the Technical Transfer / Validation of new and existing processes.
- Manage the investigation into any non-conformance, instrument malfunction, accident
- Degree in Science or other relevant field.
- More than 10 years' experience in the pharmaceutical industry and minimum of 3 years QC Laboratory Management experience.
If you're a proactive professional looking for the next step in your career, then what are you waiting for? Get in touch, today.
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Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales