Quality Systems Officer

The Company

Concept Life Sciences is a knowledge based, science led business focused on delivering the expertise and capabilities our client’s demand. We work in the pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical chemical and consumer products sectors. Our business is home to Scientists with in-depth experience in their fields, who are enthusiastic about taking on challenges. We employ problem-solvers with a proven track record in life sciences, laboratory based analytical testing and specialist consulting. We are part of the Malvern Panalytical group, which is part of the Spectris group.

The Role

In order to simplify our processes and systems we are introducing an electronic Quality Management System (eQMS) across the business to handle documentation, training and regulated quality system requirements within CLS. This role will be supporting the implementation and continued support as Subject Matter Expert (SME) and first point of contact across the company. This role is an exciting opportunity for the successful candidate to further their career, as it will touch all aspects of the business. The position will suit someone with a Quality background, who enjoys the IT side of the role and ideally has had experience of eQMS systems in previous roles. This role may also be suitable for someone who has worked in a related area who is enjoys IT and is looking for a new challenge. This role offers the candidate flexible working opportunities, as they are able to work from a local CLS site, or remotely. In addition, some travel will be required to support business and training activities in this role.

Main Duties to:

  • Assisting the Head of Quality to:
    • Implement an eQMS across CLS.
    • Identify Key processes and areas of improvement during implementation.
    • Support the completion of agreed action plans during implementation.
    • Liaise and work with the Vendor during implementation.
    • Train personnel in the use eQMS.
    • Support and maintain the use of the eQMS across CLS by becoming the First Point of Contact (FPOC) for the company and the Vendor.
    • Maintaining & improving the QMS.
    • Provision of metrics and monthly quality reports.
  • Main duties to include:
    • Support the eQMS system at all CLS sites and link in with wider Malvern Panalytical group as required.
    • Be the FPOC for colleagues and the Vendor for the eQMS.
    • Drive the day-to day activities to ensure the eQMs is an effective tool for CLS.
    • Manage the document control process within the eQMS.
    • Communicate issues/impact of changes effectively across the business.
    • Work collaboratively with the Vendor to solve problems within the eQMS in a timely manner.
    • Identify and participate in Quality Improvement activities.
    • Monitoring the system to ensure KPIs are met and escalate any issues to the Head of Quality.
    • Assist Subject Matter Experts (SMEs) to document and track processes within the eQMS, throughout the document lifecycle.
    • Develop checklists, communication documents and ‘how to’ guides for the eQMS.
    • Ensure that training logs are maintained within the eQMS.

Qualifications/Role Requirements:

  • An undergraduate degree or recognised technical diploma in a Computer Science or combination of a Life Science related field with IT knowledge/experience, or relevant professional experience.
  • Proficient in Microsoft Office and SharePoint with the ability to learn new software systems.
  • Working knowledge of systems such as Laboratory Systems, Document Management Systems.
  • Experience in the development and maintenance of Quality Management Systems within a life sciences organisation.
  • Excellent understanding of system compliance regulatory requirements and guidelines.
  • Possess a high degree of personal integrity with strong problem-solving skills and high attention to detail.
  • Excellent organisational and interpersonal skills and ability to train effectively to all levels of the organisation.
  • Ability to challenge and drive quality and a compliant culture forward and deliver against milestones.
  • Proven ability to multitask and work unsupervised.

Working Hours

  • 37.5 hours per week with flexibility required to meet the needs of the business. Some weekend work may be needed.

Company Benefits

We offer a range of learning and development opportunities depending on the role, with all employees having access to a range of internally delivered training modules as standard. In addition to a competitive salary, we offer as a minimum: Pension scheme, Healthcare Cash Plan, Retail Discount scheme, Cycle to Work scheme, Childcare Vouchers, and local Reward & Recognition schemes.

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