Main Purpose
To lead the Medical Products QC Team to ensure that a compliant and effective Analytical and Quality Control function is maintained to support the manufacture and sale of Orbia F&EM’s Medical Products.
Main Responsibilities
* Manage the shift analysts and the laboratory equipment and systems to deliver timely analysis, reporting and ultimately release (by QA) of cGMP regulated medical propellants from the QC Laboratory.
* Plan the analytical schedules ensuring adequate cover is available to meet production and sales requirements. During periods of high demand, proactively prioritise the work, liaising with other functions to agree priorities.
* Collaborate and agree with the other Team Leaders and the analytical support chemists, the maintenance and calibration schedule of the laboratory equipment, ensuring equipment is available when needed and minimising disruption of the production of medical propellants.
* Support the assurance that technical and cGMP standards of the external acceptance testing laboratory are appropriate and reflect the standards in the Medical Products QC Team.
* Assist in the hosting of cGMP and quality audits by regulatory bodies and customers, leading the tours of the laboratory and directly answering auditors’ questions and discussing any non‑conformances raised.
* Oversee the stability study activities within the laboratory.
* Plan and drive continuous improvement projects within the Medical Propellants Laboratory with a view to benefiting the Medical Business and its supply of customers.
* Liaise directly with customers and suppliers to offer method transfer and implementation, analytical and technical support as well as troubleshooting activities.
* Be responsible for SHE standards, housekeeping within the Medical QC area.
* Support the Site Quality Manager with budgeting, monitoring and controlling medical QC expenditure.
Qualifications
Desirable: Degree in Chemistry or related subject.
* Extensive experience of working in a QC Laboratory operating to cGMP standards.
* Understanding of QC in the pharmaceutical industry.
* Experience of managing a QC laboratory preferably one working to cGMP standards.
Behaviours that can help you succeed at Orbia
* Develop yourself & Others
* Drive Results
* Provide Vision & Direction
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