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Job description

COMPANY OVERVIEW

Qnostics’ core business is focused on the design, development, manufacture, and supply of specialised molecular Quality Control products for the use in the in vitro diagnostic industry. Based in Glasgow, Qnostics also works with organisations around the world to provide bespoke solutions within an ISO 13485 complaint framework. Qnostics QC products are used in over 100 countries worldwide

JOB SUMMARY

To drive the manufacturing and component build process from initiation to completion and to support the management of components across the business.

To drive operational improvement projects to deliver solutions in line with the specifications and timelines. This will require the evaluation of new processes and equipment, completion of validation, verification of performance, reporting on findings and making recommendations to the management team.

In line with the Quality management system, ISO 13485 and the IVD Regulations, facilitate the transfer of new processes and equipment into routine operational use. Defining SOPs and training out processes to members of staff.

Where required the role involves the supervision and development of routine/new manufacturing operations, these duties include

• Ensuring that all manufacturing activities, products, and projects are delivered to the agreed schedule and to the appropriate quality standard (ISO13485).
• Ensuring that staff within the Manufacturing team are appropriately trained in the build and aware of all associated processes and procedures
• Development, preparation, testing and release of component builds

KEY ROLES & RESPONSIBILITIES

The role of the Production Supervisor is to:

• Develop, prepare, test and release component builds on schedule.
• Support Stock Management in the management and use of components.
• To drive projects forward from initiation to implementation, ensuring that all stakeholders are involved / kept informed at all stages of the development.
• Maintain and managing project build timelines and reporting
• Maintaining all associated build manufacturing documentation, processes, procedures and ensure that any documentation is appropriately checked and authorised
• Ensuring that all stock required to facilitate a build activity is appropriately procured and requisitioned prior to the manufacturing activity / task taking place.
• Developing training materials and carry out training in support of builds where necessary
• Guiding and inform competence of manufacturing technicians and validation of any process variations
• Leading trouble shooting activities of events raised through quality (e.g. NCs, CAPA, etc) and support the appropriate and timely closure and effectiveness review of such events
• Maintain and extending own competence in all production activities
• Support the Manufacturing Manager in all aspects of people and performance management

Other activities:

• Assist with other supervisory activities in other departments where required (R&D, Logistics or Stock Management, etc.)
• To undertake other duties which may arise or as may be delegated from time to time, subject to the needs of the business.

SKILLS & EXPERIENCE

Experience:

• Experience in diagnostics manufactures
• A detailed knowledge of manufacturing process validation and verification within an IVD framework.
• Experience in the writing of and training on processes within an IVD quality framework
• Experience in manufacturing within the IVD industry to ISO13485 or within an equivalent life science / biological product manufacturing environment.
• A fundamental understanding of GLP / GMP and the requirements of ISO13485
• Proven project management / planning skills
• Experience in the supervision and line management of operations staff / technicians.
• Highly competent in identifying training needs and training others to meet operation standards
• Life Science background (degree/HND/HNC) would be an advantage but not essential.

Skills:

• Strong report writing and the ability to communicate complex ideas in simple English.
• Excellent communication, presentation, and negotiation skills
• Strong customer focus and interpersonal skills
• Adaptable and flexible
• Excellent teamwork and people management skills with the ability to motivate and encourage others
• Good analytical, problem solving, planning and organizing skills
• Results focused, with ability to work on own initiative
• Competent in Microsoft Office Suite: especially excel

SALARY : From £24,000 dependent on experience

Job Type: Permanent

Benefits:

• Company pension
• Private medical insurance

Schedule:

• Day shift
• Monday to Friday
• No weekends

Work Location: In person