Computer System Validation Specialist

About The Job
Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients’ projects and to the Company. Southern Star Research’s culture is focused on fostering and maintaining a positive, professional and productive work environment.

Due to continued growth and a strong project pipeline, we’re looking for a talented full-time Computer Systems Validation Specialist to join our team remotely in either the Philippines, India or Malaysia. You’ll take the lead on maintaining compliance, complete ongoing CSV for established clinical systems, as well as conducting all initial CSV for new system implementation and significant updates.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About The Role
Reporting to the Head of Quality Assurance, you’ll be responsible for:

• Maintain the corporate GXP computerised system inventory.
• Track and manage the conduct of CSV and related tasks for GXP systems.
• Liaise with System Owners to ensure the computerised systems are maintained in a validated state.
• Development or review and approval of proposed and executed Clinical Trial Computerised system change control for CSV related projects (e.g., new system implementations, major upgrades).
• Collaborate with and support the IT team with responsible monitoring of computerised system purchases, installation, validation, continued evaluation to decommissioning of these systems using a risked based approach.
• Review of vendor supplied CSV documentation (e.g., change request, risk assessment, validation plan, software/configuration/functional specifications, IQ/OQ/PQ, traceability matrix, validation report) for suitability during initial assessments and system updates.
• Creation, review and approval of internal CSV documentation (e.g., initial assessment, change control, URS, risk assessment, validation plan, software/configuration/functional specifications, IQ/OQ/PQ, traceability matrix, validation report).
• Create, review and approve CSV SOPs and provide guidance and training to others on CSV SOPs where required.
• Ensure annual reviews of user access and periodic reviews are performed for computerised systems and actively participate in this process through review / approval of the documentation.
• Liaise with System Owners, Head of QA and IT Management to determine CSV needs and strategic goals.
• Ensure regulatory requirements are applied and adhered to as applicable throughout the CSV life cycle of regulated systems.
• Perform CSV activities in accordance with internal SOPs.
• Conduct internal process audits to verify compliance with internal processes and applicable regulatory requirements.
• Assist with vendor assessments and audits conducted by sponsors.
• As required, contribute as a member of the investigational team for CAPAs related to clinical trial systems and CSV.
• Maintain an up-to-date knowledge of the latest requirements relating to CSV, cybersecurity and GCP and regulatory requirements in Australia and overseas.
• Other duties as directed by Line Management or delegate.

Does this sound like you?

To be successful in the role, we’re looking for candidates with:

• Bachelor’s degree (preferably in a science or IT field) or equivalent experience.
• Minimum 2 years’ experience operating in a GCP or GxP environment with experience in a CSV capacity in a GxP (preferably GCP) environment.
• Formal audit exposure.
• Previous experience in Veeva Vault CTMS and/or eQMS experience essential.
• Demonstrated ability to prioritise work, manage multiple priorities and deliver tasks on time with a high degree of accuracy.
• Good written and verbal communication skills with a demonstrated ability to communicate effectively with senior management and other departments.
• Demonstrated ability to work harmoniously and cooperatively with other people and to work independently without supervision.
• A proactive and enthusiastic team player who is willing to identify issues and propose solutions.
• Intermediate – advanced MS Office suite.
  

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity for someone who is looking to contribute towards our expansion into the APAC region and join a passionate team that’s committed to quality, collaboration, and continuous improvement. Southern Star Research are also proud to be certified as a Great Place To Work in Australia!

We Offer
An attractive remuneration and benefits package;

• Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
• We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
• Career stability and security and more!

We’d love to connect with you!

Don’t have the all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality
Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Please note that only successful candidates will be contacted.