We are looking for a scientific graduate at our client's site in south Yorkshire. The successful candidate will come from a scientific background, ideally with experience of pharmaceutical manufacture or Quality Control in a GMP environment.
To help ensure our client's compliance with the requirements of Good manufacturing Practice and Regulatory Rules and Guidelines and contribute to the company quality assurance functions.
- Preferably, experience in Quality Assurance for production of Sterile injectable products but is not essential.
- Ideally has a practical experience in activities of quantitative and qualitative analyses of active substances and of the necessary testing and checking to ensure the quality of medicinal products or associated relevant experience.
- To ensure that batch records and other documentation is completed to the expected standards during the Batch Review and Release process.
- To ensure, via the site Qualified Person, that the Quality Management System is managed and maintained to the requirements and standards set down in Company Policies.
- To collate process deviations and laboratory investigations ensuring that problems are addressed in compliance with GMP and our client's procedures.
- To prepare information for the periodic Quality Management Meetings and track the performance against KPIs and the specified standards.
- To monitor the nature, extent and frequency of complaints
- To co-ordinate recall/withdrawal procedure.
- To support site validation activities ensuring that regulatory requirements are met.
- To co-ordinate and carry out internal site auditing programmes.
- To act as an advisor to the site team in aspects of Quality and Continual Improvements.
- To take part when required in site Inspections by Regulatory Authorities.
- To help ensure that the RPU is Inspection ready at all times.
- To support Continual Improvement where necessary as part of ongoing systems management.
- To take part in the regular Quality Management Meeting
- To participate in our client's Safety Committee meetings.