Description
A leading pharmaceutical organisation is in need of a Qualified Person (QP) with experience of batch release on Oral Solid Dose/IMP products.Role:
• Named on the company’s Manufacturing license under EU/Mhra regulations.
• Batch release of Oral Solid Dose Presentations (OSD)/IMP products.
• Support clients in matters relating to regulatory submissions.
• Remain up to date on the changes in regulatory matters and the effects of these both internally and for external regulatory authorities.
• Develop and implement programs to assure compliance with regulatory (MHRA and others) requirements, as well as the standards for quality and performance set by internal and external stakeholders.
• Create, maintain and champion a culture of exceptional quality, regulatory compliance.
Role requirements:
• Bachelor's degree in science or life science.
• Registered and practising cGMP Qualified Person under permanent provisions.
• Strong Background working within a highly regulated Pharmaceutical manufacturing environment with specific experience of batch release on Oral Solid Dose (OSD) presentations.
• Experience of working within a MHRA/FDA approved environment.
• Experienced in IMP’s, clinical trial services as well as commercial batch release.
• Thorough knowledge of cGMP’s and pharmaceutical manufacturing requirements.
• Experience in leading/taking part in MHRA/FDA inspections would be beneficial.
• Competent in basic computer software packages e.g. Microsoft Office.
• Hands-on approach with a ‘can-do’ attitude.
• Must be a self-starter who is motivated and able to work under own initiative.