Job Description
Our client develops and manufactures novel innovative dosage forms and solutions to its customers in the health care industry. The company’s solves customers’ most pressing product development challenges, including bioavailability enhancement, modified release, abuse deterrence, biotherapeutics processing, and inhalation formulation.
This is a business critical hire to ensure the execution and maintenance of the existing batch release systems, scheduling release programs and batch review procedures; manage and co-ordinate the batch release activities to ensure compliance with committed timelines, relevant regulations and guidance. These activities will include review of new clinical products; existing clinical products, existing commercial products; regulatory/client interactions where appropriate and review of all related documentation. In addition gaining up to date knowledge of supporting systems and current regulatory requirements to ensure that commitments and legal requirements are met.
The role requires a scientific background and a qualified QP with s strong Quality Assurance/Control and Quality Systems background
Demonstrated experience of GMP and regulatory standards within a Pharmaceutical manufacturing environment (MHRA/FDA)
First class communication skills at all levels, is required to influence others positively and the role holder must ability to train, guide and mentor others.
