Data Validation and Support Specialist

360biolabs is Australia's most comprehensive quality-accredited specialty laboratory services organisation. 360biolabs is a BioAgilytix company and part of a leading global contract research organisation (CRO) supporting the development of innovative new medicines in a quality-controlled environment. At 360biolabs, we develop and conduct pharmacokinetics (PK) and pharmacodynamic (PD) assays across a wide variety of therapeutic areas to ensure the success of our clients' clinical trials and preclinical studies.

Working at 360biolabs means working with the best people (and technology) in our field. With a genuine focus on development, you will have access to local and global opportunities. You will also have access to a diverse offering of wellbeing and connection initiatives which reflects that people are our priority.

To provide IT and application support for a range of scientific applications, with adherence to industry best practice and relevant regulatory guidelines.

The key responsibility areas (KRAs) are major outputs for which the position is responsible and not a comprehensive statement of all position activities.

Information Systems

Be actively involved in performing Computer Systems Validation activities, particularly with spreadsheets validation as according to the spreadsheet validation SOP.

Create, update and/or review validation documents including but not limited to spreadsheet/user requirements, test plans, IQ/OQ/PQ tests, UAT and reports

Writing and reviewing validation documentation that meet regulations and requirements, including change management activities

Facilitate and conduct functional risk assessments

Liaise with stakeholders (vendors, subject matter experts, testers) in the planning and execution of CSV projects

Includes prospective, concurrent and retrospective validation

Includes spreadsheet validation

Where required, prepare spreadsheet templates and validate their use according to SOP.

Review spreadsheet templates if prepared by others and assist in validating their use

Be involved in maintaining validation of computerised systems and spreadsheets

Assist in maintaining Computer Systems Validation SOPs and Templates

Must be highly proficient with the use of Excel, particularly with formulas, functions and protecting spreadsheets

Provide application support for a wide range of scientific applications. This includes covering the entire lifecycle of application systems, from strategy through to support and retirement

Be involved in investigating, analysing hardware and software problems, and ensuring relevant validation documentation are updated

Contribute towards scientific system upgrades, installation, integration, customisation and configuration, and ensure validation documents are updated accordingly

Maintain effective communication with users when resolving incidents and fulfilling requests

Accreditation

Adhere to ISO/IEC 17025, OECD Principles of GLP, GCLP Principles, 360biolabs’ Quality Management System, and other requirements as relevant per NATA Accreditation and regulatory guidelines.

Team Work

Maintain high levels of communication with colleagues

Collaborate well in a cross functional matrix environment

Safety

Ensure the safe and efficient conduct of company activities

Ensure compliance to relevant internal processes and statutory requirements

Professional Development

Attend meetings associated with Information Systems or the work of 360biolabs

Participate in professional activities including attendance at training courses and seminars in the field of expertise

Qualifications

Degree in Science or IT or equivalent plus relevant experience (Essential)

Experience / Knowledge / Attributes

High degree of self-motivation with the ability to work independently and to effectively manage and prioritise work (Essential)

Eagerness to learn, be pro-active and willing to share knowledge (Essential)

Strong analytical and problem-solving skills; ability to perform root cause analysis (Essential)

Approachable individual that is dedicated to providing friendly support, as well as willing to go the extra mile (Essential)

Excellent administrative and organisational skills (Essential)

Experience in writing computer system test scripts, validation protocols and summary reports (Essential)

Experience in technical writing in both validation and QMS documentation (Essential)

Good interpersonal skills to facilitate interaction among staff and project teams (Essential)

Ability to work effectively as part of a multi-disciplinary team (Essential)

Excellent analytical, interpersonal, verbal and written communication skills (Essential)

High level of attention to detail (Essential)

Working knowledge of IT hardware and software, including Windows Server and Desktop OS (Essential)

Highly proficient with Microsoft Excel, particularly with formulas and functions (Essential)

Good understanding on version control with documents and spreadsheets (Essential)

Broad knowledge and exposure to computer systems validation principles and methodology, including quality guidelines and regulations (GxP) (Essential)

Good knowledge of regulations applicable to computerised systems (eg US FDA 21 CFR Part 11, GLP) (Essential)

Knowledge and exposure to systems such as LIMS and Document Management Systems (Desirable)

Experience with Excel macros and VBA (Desirable)

Knowledge and exposure to computerised systems validation (Desirable)

Basic knowledge of ‘good practise’ of quality guidelines and regulations (GxP) (Desirable)

Ability to work independently on multiple concurrent projects with minimal guidance (Desirable)

Experience working in a Scientific Environment (Pharma/Biotech) (Desirable)

Experience working with a range of scientific software (Desirable)

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