IT Engineer

  • Chemistree Solutions Ltd
  • Abingdon, UK
  • 01 Nov, 2020
Full Time Information Technology Telecommunications

Job Description

Role: Technical Quality and Compliance Manager

Therapy Area: Diagnostics - Infectious Disease & Cardio-metabolic

Package: Competitive package based on experience, pension, private health, and additional benefits

Location: Abingdon

This is a great opportunity to join an established world leading healthcare company as a Technical Quality and Compliance Manager.

Role Type: Technical Quality and Compliance Manager

The client is a world leader in rapid diagnostics at the point of care, with a focus on cardio metabolic disease, infectious disease and toxicology.For more than 125 years, they have brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals. Employing more than 99,000 people worldwide to help people live not just longer, but better, in the more than 150 countries.

The Technical Quality & Compliance Manager is the go-to subject matter expert for all quality and compliance controls for the IT department around software and hardware development, support and maintenance.In this role you will report to the Director of IT and you will be responsible for identifying, leading, and/or supporting quality, regulatory, and compliance improvement initiatives, projects, and remediation activities at site, cross-site, and Business Unit levels. This position will focus on implementing and maintaining an effective document control process for the Business Unit and deploying Quality System programs to the Toxicology Business Unit.

This position is responsible for ensuring that the IT department practices, policies and processes are performed in accordance with quality, compliance, contractual, security and regulatory requirements. This position will leverage program management experience to drive key compliance initiatives, support and advise teams across the IT department on risk, and work in cross-functional partnership to help ensure those requirements are met.This position can interface with Quality functions, other Business Units, independent 3rd party auditors, partners, vendors, and customers in association with the quality and compliance area. Responsibilities:

This role supports the development, implementation, improvement, and/or effectiveness of the IT Technical Quality and Compliance Systems in compliance with applicable ISO, FDA, and other regulatory agency regulations and standards through implementation of effective Technical Quality System programs

Identify and document validation requirements for commercial IT systems and laboratory software systems (including instrument application software) and interfaces

Development of a master validation plan for commercial IT systems and laboratory software systems and interfaces

Conduct risk analysis, design mitigation plans, and implement necessary controls

Acts as a Subject Matter Expert in Technical Quality System areas such as Document Control, Management Review, Quality Metrics, and Inspection Readiness, while sharing knowledge through best practices and risk mitigation strategies

Works directly with entities in establishing compliant Technical Quality System processes and programs

Leads or assists internal and external audits as assigned

Execution of validation protocols generating reports including validation reports and risk assessments as required

Review and document laboratory requirements, define and implement procedures for instrument and data management / data integrity

Interact with equipment vendors and IT partners to support the development and implementation of data integrity controls

Able to support multiple business priorities and deadlines

Collaborate effectively with individuals and teams within the IT department

Mentor colleagues and team members on technical quality and compliance best practices and controls

Conducts periodic formal training in technical quality and compliance topics for the IT department

Assists in building a technical quality and compliance awareness program for the company

Maintain knowledge in the technical quality and compliance areas

Minimal travel between sites may be required for this position

Qualifications

Bachelors degree in Computer Science, Computer Engineering, Engineering related degree, and/or equivalent work experience

Current driving license preferred

Person/Experience Required

Significant practical experience of software development life cycle activities

Thorough knowledge and practical application of Quality System Regulations regarding commercial and lab software and IT hardware

Knowledge of computerised software validation requirements and procedures for laboratory instrumentation e.g. LC-MS, Immunoassay platforms, software, hardware and instrument qualification

Experience of development and implementation of a software validation structure

Significant experience in Quality Assurance testing or related industry with exposure to quality practices and quality processes

Has an in-depth understanding of quality management systems, testing best practices and data integrity

Experience with running a technical quality and compliance program and identifying risk

Experience with leading audits by external parties

Ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds

Prior experience with FDA or related audits

Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and best practices and give oral presentations

Technical knowledge of enterprise software development is preferred

Demonstrated ability to set and meet tight deadlines and function well under pressure

Contact Information

Chemistree Solutions Ltd is a healthcare recruitment specialist. We believe that successful recruitment lies at the heart of business success. Our aim is to match your talent to the opportunity...... click apply for full job details