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Compliant Cloud is an innovative company delivering next generation services and products to regulated companies. Our policy is to partner with companies who need to achieve regulatory compliance in a cost effective and efficient manner while providing a platform for continuous improvement. We work with organizations worldwide to establish and maintain best in class GxP Computerized Systems through our on-premise and GxP Cloud offerings. Why not be a part of our team?

CSV Engineer

Capable of integrating into a global projects team with responsibilities for generation, signoff & execution of various project & cGMP related document and protocols including Validation Master Plan, URS, FDS/DS

SKILLS

The following skills & knowledge would be deemed beneficial:

  • Be a self-starter and be motivated to provide a solid product quality and customer experience
  • Be adaptable to a fast pace working environment
  • Be able to integrate and interact well within a customer environment
  • Have good communication skills, both written and verbal
  • Have excellent Microsoft Office user level skills
  • A passion to learn and to contribute to a team effort

Beneficial Experience

  • Experience is not mandatory however any experience in the following key topics would be beneficial:
    • Management, development and/or validation of GxP Computerised Systems
    • Prior experience in working with cGMPs and/or GLPs,and Quality Systems
    • Experience working in the Pharmaceutical / Medical Device industry
    • Experience with compliance and associated activities from other industries such as insurance, healthcare etc

JOB DESCRIPTION

Graduate CSV typical tasks / activities will include:

  • Development of GxP Computerised Systems Lifecycle documents across the entire validation lifecycle for all types of GxP assets e.g. Lab, Automation, Business and Equipment systems
  • Provide assistance where required with the preparation/testing of validation protocols, and all associated documentation for GxP Computerised Systems
  • Review/Approval of all GxP Computerised Systems Validation Documentation.
  • Administration of GAMP lifecycle across projects
  • Adhere to Odyssey VC Quality Management System (QMS) Policies and Procedures
  • Maintain training in accordance with Odyssey VC QMS
  • Any other duties which may be assigned from time to time

Education

  • A Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or three years relevant experience)

How to Apply Click the ‘Apply’ button below or send your application to careers@odysseyvc.com quoting ‘OVC-CSV-GRAD’ in the subject

Digital Marketing

Capable of integrating into a global projects team with responsibilities for generation, signoff & execution of various project & cGMP related document and protocols including Validation Master Plan, URS, FDS/DS

Data Analytics

Capable of integrating into a global projects team with responsibilities for generation, signoff & execution of various project & cGMP related document and protocols including Validation Master Plan, URS, FDS/DS

Skills

The following skills & knowledge would be deemed beneficial:

  • Be a self-starter and be motivated to provide a solid product quality and customer experience
  • Be adaptable to a fast pace working environment
  • Be able to integrate and interact well within a customer environment
  • Have good communication skills, both written and verbal
  • Have excellent Microsoft Office user level skills
  • A passion to learn and to contribute to a team effort

Beneficial Experience

  • Experience is not mandatory however any experience in the following key topics would be beneficial:
    • Management, development and/or validation of GxP Computerised Systems
    • Prior experience in working with cGMPs and/or GLPs,and Quality Systems
    • Experience working in the Pharmaceutical / Medical Device industry
    • Experience with compliance and associated activities from other industries such as insurance, healthcare etc

Job description

Graduate CSV typical tasks / activities will include:

  • Development of GxP Computerised Systems Lifecycle documents across the entire validation lifecycle for all types of GxP assets e.g. Lab, Automation, Business and Equipment systems
  • Provide assistance where required with the preparation/testing of validation protocols, and all associated documentation for GxP Computerised Systems
  • Review/Approval of all GxP Computerised Systems Validation Documentation.
  • Administration of GAMP lifecycle across projects
  • Adhere to Odyssey VC Quality Management System (QMS) Policies and Procedures
  • Maintain training in accordance with Odyssey VC QMS
  • Any other duties which may be assigned from time to time

Education

  • A Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or three years relevant experience)

How to Apply Click the ‘Apply’ button below or send your application to careers@odysseyvc.com quoting ‘OVC-CSV-GRAD’ in the subject

Cloud Specialist

Capable of integrating into a global projects team with responsibilities for generation, signoff & execution of various project & cGMP related document and protocols including Validation Master Plan, URS, FDS/DS.

Full Stack Developer

Odyssey VC uniquely offer Integrated Compliant Cloud and Computerised System Lifecycle Management Services to Life Science companies that operate in highly regulated environments. The Full Stack Developer will have an important role in supporting the Odyssey VC business goals and will be required to exercise initiative, drive and enthusiasm in delivering these solutions. Odyssey VC are continually developing the Compliant Cloud product and need to evolve the technology as well as the engineering and delivery capability underpinning the solution. As a Full Stack Developer at Odyssey VC, you will work with a broad array of technologies in the Life Sciences space. As an experienced member of an agile developer team you'll be responsible for taking part in the development of Odyssey's internal full stack web applications, integrating with external services and testing and deployment of the applications. Environments will include private and public clouds (e.g. Amazon Web Services, Azure).

SKILLS

As Full Stack Developer, you will be responsible for, but not limited to:

  • Creating microservices in NodeJS;
  • Creating front-end applications with React;
  • Participating in DevOps related tasks;
  • Being responsible for technology-related decisions;
  • Developing, deploying, maintaining, troubleshooting and improving inhouse service products;
  • Adhering to Odyssey VC’s standards and utilising the approved tools, best practices and mode of operation;
  • Participating in multiple projects with various priority levels and time lines;
  • Continuously staying abreast of new developments in supported technologies;
  • Participate in designing innovative solutions to improve current procedures;
  • Act as service owner and process owner as per the IT Framework;
  • Maintain accurate change control as per the Odyssey VC change management process;
  • Adhere to all Odyssey VC quality and operational procedures and ensure quality and compliance at all times;
  • Develop and maintain accurate documentation for internal procedures and services;
  • Demonstrating best practices in all aspects of administration;
  • When required by the business, participate in weekly rotating on-call responsibilities, providing 24/7 coverage;
  • Coaching and educating other colleagues in Agile Development and best practice;
  • Supporting the build up of the Development team.

Person Specification Knowledge of:

  • Windows and Linux operating systems
  • Cloud services and technologies
  • Security / cybersecurity threats, security tools and best practices

Essential:

  • Self-starter – able to work on own initiative
  • Ability to manage and work in a matrix environment
  • Strong customer focus ethos with a service mindset
  • Excellent communication skills with ability to communicate in technical and non-technical language
  • Solution driven with ability to execute quickly
  •  Strong problem resolution, judgement and decision-making skills
  • Excellent analytical skills
  • Passion for innovation, excellence and change
  • Ability to deal with change and ambiguity
  • Accuracy / Attention to detail

Desirable:

  • Agile Methodologies: Experience with Agile software development and project management methodologies

Qualifications

  • A Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field with 2-5 years’ experience in software development.
  • Must have full stack experience in developing web applications using JavaScript, Node.js, HTML and CSS.
  • Must have Web UI knowledge and best practice skills, with experience in React, possibly other front-end frameworks.
  • Must have experience with relational databases and SQL skills.
  • Knowledgeable in using development tools, testing frameworks and techniques (JIRA, GIT, Jenkins, Selenium, XP/TDD).
  • Experience with TypeScript is a plus.
  • Experience in Amazon AWS, Docker and microservices is a plus.
  • Experience working with high load and high traffic production systems is a plus.
  • Good English language communication (verbal and written) and presentation skills.
  • Must be able to provide accurate estimates of technology work and deliver high quality work on schedule.
  • Strong desire to improve upon their skills in software development, frameworks and technologies.
  • Preferable to have experience working in highly regulated environments.

IT & Compliance Specialist

The IT & Compliance Specialist has an important role in the development of the Odyssey VC business goals and will be required to exercise initiative, drive and enthusiasm in achieving these goals. This role will maintain the Company's effectiveness and efficiency by helping to bridge the gap between IT and Compliance.

Main Responsibilities & Duties

  • Technical liaison for all system implementations/projects for Odyssey VC and their customers.
  • Ensuring software is controlled and stored as per validation procedure guidelines.
  • Generation, signoff & execution of various external and internal project & cGMP related document and protocols including Validation Master Plan, URS, FDS/DS, traceability matrix, test specs, IQ, OQ, Integrated OQ & PQ, relevant summary reports and change controls.
  • Administration of GAMP lifecycle across concurrent projects.
  • Provide compliance oversight and training to IT Team.
  • Applying critical patches/hotfixes to compliant systems under change control.
  • Develop back-up and recovery plans for Odyssey VC and customers.
  • Develop disaster recovery plans for Odyssey VC and customers.
  • Monitoring and management of Odyssey VC and customer infrastructure

Person Specification 

Solution driven with ability to execute quickly

    • Strong problem resolution, judgement and decision-making skills
    • Excellent analytical skills
    • Strong customer focus ethos
    • Self-starter with strong analytical, innovative and achievement capabilities
    • Passion for excellence and change
    • Ability to deal with change and ambiguity
    • Team-player
    • Excellent communication skills
    • Accuracy / Attention to detail

Essential:

  • Self-starter – able to work on own initiative
  • Ability to manage and work in a matrix environment
  • Strong customer focus ethos with a service mindset
  • Excellent communication skills with ability to communicate in technical and non-technical language
  • Solution driven with ability to execute quickly
  • Solution driven with ability to execute quickly
  •  Strong problem resolution, judgement and decision-making skills
  • Excellent analytical skills
  • Passion for innovation, excellence and change
  • Ability to deal with change and ambiguity
  • Accuracy / Attention to detail

Desirable:

  • Server and client operating systems (Linux, Windows, Unix)
  • Virtualisation and Storage concepts
  • General understanding of different computer coding languages (MQSQL, MySQL, Java, Visual Basic etc)
  • Cyber security
  • Designing Cloud Computing Solutions & Services tailored to customers’ needs.
  • Managing the specification, development and installation of projects within budget and guidelines.
  • Strong ‘Life Science’ system knowledge.
  • Identifying and implanting new innovative technologies

Relationship with Others:

  • Reports directly to IT Manager

Scope of Position:

This profile is a guideline for the role and may develop or change in accordance with the individual, their manager or business demands.

 

Service Support Manager

The Service Support Manager will have an important role in the development of the Odyssey VC’s service and operational capability and will be required to exercise initiative, drive and enthusiasm in achieving the business goals. Maintains the Company's effectiveness and efficiency by: • Defining the end to end delivery and support model and liaising with all parties to ensure KPIs and SLAs are met in operations. • Continually advocating for the customer and maintaining high levels of customer satisfaction. • Providing feedback and customer insight back to the business to ensure continuous improvement.

Main Responsibilities & Duties

  • To take end to end accountability for all services delivered by Service Support at agreed service levels to our customers through all internal and external partners within the end-to-end support chain at the lowest possible cost.
  • To contribute towards the definition of customer SLAs and operational KPIs.
  • To ensure that SLAs are adhered to and that effective processes and systems are introduced to monitor the achievement of SLAs.
  • To respond rapidly to critical situations ensuring timely escalation to the management team.
  • To ensure the operational support model is in place including provisions for responding to customer queries (webchat, phone, email and service tickets), leveraging ITIL processes and monitoring systems and environments.
  • To implement ITIL processes for incident management, problem management, service request management, operational change management, order fulfilment, and continuous service improvement.
  • To protect the quality of critical services by identifying operational risks and implementing mitigating actions.
  • To ensure that new service commitments do not compromise existing contractual obligations.
  • To ensure that technology changes are assessed, contracted, tracked and implemented in a manner that maintains operational integrity.
  • To identify service needs and opportunities, support the process to develop and sell proposals to customers, and facilitate and monitor the delivery of projects and introduction of new or changed services.
  • Control and steer the performance of internal and external partners within the operating model, using benchmarking and KPIs.
  • To contribute to, and sometimes lead, the IT roadmap projects where required.
  • Ensure compliance with relevant legal and compliance certifications & standards.

Person Specification 

Knowledge and Experience

  • >5 year of experience in the operation of complex services organisations.
  • Experience in the definition and design of complex service operations solutions.
  • Proven experience in customer relationship management.
  • Budget and Cost Management.
  • Drive for effectiveness and efficiency improvements.
  • Proven ability to build high performing teams.
  • Knowledge of helpdesk management tools, online customer portals, online payment tools and document management systems is an advantage.
  • Broad technical knowledge.
  • Solution driven with ability to execute quickly.
  • Strong customer focus ethos and a service mindset.
  • ITIL experience/certification desirable.

Education & Experience

  • Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or 5 years’ relevant experience).
  • Excellent communication and interpersonal skills.

Relationship with Others:

  • Reports directly to IT Manager

Scope of Position:

This profile is a guideline for the role and may develop or change in accordance with the individual, their manager or business demands.