Sector: Life Sciences
Consultant: Life Sciences Team
Salary: £35000 - £45000
Job Status: Permanent / Full Time
I’m working with a fantastic organisation looking to bring in an additional Quality Manager due to continued growth and work load, I have worked with this client on a number of other Quality Manager roles so we are unique position of been able to get you through the door a lot quicker, for the right person my client will move quickly to interview and progree.
Working with the other Company’s Responsible Persons (RPs), maintain the Quality Management System (QMS) and ensure compliant implementation at both sites through coaching, mentoring and training.
- Working with the other Company Responsible Persons (RPs) review and update the QMS to ensure regulatory compliance to current GDP guidelines for the sites
- Implement and monitor all aspects of the QMS, working with appropriate staff at the GDP sites
- Review, update and implement Standard operating procedures (SOPs) and training records and associated specifications, forms and records
- Develop and monitor implementation of a system of self-inspection and RP audits
- Ensure CAPAs are developed and completed when appropriate
- Ensure change controls are developed and completed when appropriate and the changes are monitored, reviewed with adequate training provided to relevant sites and personnel
- Ensure deviations are being recorded appropriately at the various sites and that appropriate actions are developed and completed as a result
- Ensure technical agreements with third party suppliers of equipment and services are fit for purpose and up to date.
- Implement the QMS through development and delivery of appropriate training to relevant staff and additionally through appropriate coaching and mentoring
- Assist with MHRA, client & third party inspections and co-ordinate to ensure responses are appropriate and compliant and feedback to the other Company Responsible Persons.
- Communicate, through development and measurement of KPIs and analysis and trend features of the QMS which indicate compliance, report the outcomes to the group.
- Scientific degree or relevant experience within the pharmaceutical industry to Responsible Person level
- Detailed knowledge of current GDP requirements and some knowledge of current GMP requirements
- Good understanding of the pharmaceutical wholesaling/pre wholesaling sector in the UK
- Demonstrable strong leadership capabilities
- Capable and confident communicator (written and verbal) at all levels with first class presentation skills
- Commercially astute and customer focused
- Demonstrable analytical and problem solving abilities
- Excellent project management skills and demonstrate completer-finisher abilities
- Have a hands-on approach with an enthusiastic can-do attitude
- Have the ability to self-motivate and motivate others to deliver
- Demonstrable coaching and mentoring skills
- Prepared to travel to the various sites within the Company on a regular basis, with overnight stays if required