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An expert in GLP and cGMP, this role is responsible for the Quality Management System and the oversight of quality and compliance for Assured Micro Lab. Management of the QMS includes validation, analysis of data, considering trends, determining appropriate actions, and enabling continuous improvement. Communicator of QMS status, risks, and compliance to senior management. Oversight and management of the commercial Assured Micro Laboratory Team and responsibility for day-to-day operation of the Assured Micro Laboratory including hosting MHRA audits.
Job Responsibility:
Overall management of GMP Quality Management System
Maintenance of Training System, Quality Reports, Standing Operating Procedures (SOP), Corrective and Preventative Actions (CAPAs), change controls, complaints, and incidents
Review/approval/control of cGMP documentation including Testing Documents, Testing Reports, Testing Maps, logbooks, and equipment diaries
Review/approval/ control of all quality management documentation
Manage supplier certificate and conduct supplier audits when required
Management, planning and hosting of MHRA, certification, supplier, and client audits
Co-ordinate and manage the internal audit schedule ensuring compliance with departmental procedures and EU GMP regulations
Analysing, trending, and reporting of data
Driving continuous improvement through the QMS
Day to day supervision onsite of the Assured Micro Laboratory and Team, overseeing activities including sales to ensure compliance with all company policies including health and safety, quality, and general procedures
Working closely with our Technical Sales and Assured Micro Finance Team to collaborate and advise on sales from a technical perspective and to ensure an effective process is in place
Providing technical advice to our customers as required
Responsible for ensuring lab and quality issues are solved while considering continuous improvement within the business
Coach and mentor all personnel with reference to Quality, Compliance and GMP, including ownership for the GMP training system
Support with as appropriate with our company wide ISO 9001, ISO 17025 at our Lab in Skegness, on site quality checks for our Cleanroom Team and other accreditation or internal audit as appropriate
Requirements:
Degree Level or above in a scientific field
CQI & IRCA-Certified Lead Auditor or equivalent
Extensive GLP and cGMP knowledge and relevant qualifications including CAPA and deviations, batch review and release, change control, supplier approval, and management
Laboratory testing and calibrations
Leadership of a Laboratory or Quality function
Appropriate cGMP validation experience (IQ/OQ/PQ), Computerised System Validation (CSV), Method validation, risk management, process and cleaning validation and document and record keeping (GDP/ ALCOA principles)
MHRA and regulatory readiness experience
What we offer:
A generous yearly bonus paid every January, to all staff
30 days’ annual leave (including bank holidays), increasing to 33 days for loyalty service
Company Sick Pay scheme
Company pension contributions of 5% of salary
Employee Assistance Programme (EAP), private counselling and other schemes to support employees with their mental health and wellbeing
A growing, family owned, highly successful business, with a history spanning back to the 1920s
Highly committed to investing in people and training, with a proven history of opportunities and promotions from within for employees who wish to progress
A great culture, represented in our company values known as the SKIEs