Quality & Laboratory Manager (Assured Micro)

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. Duties to include:

• Overall management of GMP Quality Management System. Accountable and responsible for but not limited to:
• 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.
• 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, Disability Confident
About Disability Confident A Disability Confident employer will generally offer an interview to any applicant that declares they have a disability and meets the minimum criteria for the job as defined by the employer. It is important to note that in certain recruitment situations such as high-volume, seasonal and high-peak times, the employer may wish to limit the overall numbers of interviews offered to both disabled people and non-disabled people. For more details please go to .
Micronclean's culture is captured within the Micronclean SKIEs. These four principles - Stewardship, Knowledge, Innovation and Excellence provide a compass for our strategic direction, help inform day to day business decisions and keep our customers firmly at the centre of everything we do. A candidate's character affinity to our culture will be paramount to their suitability for this role. A copy of our vision and values (the Micronclean SKIEs) can be found here: [ Why Work for us as a Quality and Laboratory Manager? There are many reasons to join the Micronclean family, but here are just a few:
• 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., Assured Micro has recently joined the Micronclean group and was founded in Glasgow in 2009 to support customers who do not have an
in-house Microbiology department. Today, Assured Micro provides a range of integrated services to companies throughout Scotland, the North of England and further afield. Micronclean is a family-owned business based in Lincolnshire employing over 450 people. The company provides products and services to various industries. Our current focus areas include rental of specialist work wear to cleanroom industries (pharmaceutical, medical devices, aerospace. The company also manufactures and distributes a range of cleanroom products, which it sells in the UK and exports throughout Europe and further afield, including India, Australia, and Canada. The company has an ambitious vision for growth both in the UK where we are investing in all our plants and abroad. where our plant in Bangalore, India has recently been commissioned.