Csv Specialist

**Due to continued business growth we are seeking an experienced CSV Specialist. This role can be based at any of our four office locations (Adelaide, Brisbane, Melbourne, Sydney) or remotely from your home location. Whichever works best for you.**

**Who are we?**
We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

**Why should you join Avance Clinical?**
We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

**The role**
The Computerised System Validation Specialist is responsible for supporting the development, implementation and maintenance of the Computerised systems at Avance and participating in Avance quality assurance program as per related policies and procedures to ensure compliance with Good Clinical Practices (GCP) and other regulations.

**Responsibilities**
- Maintain the computerised systems inventory and other working documents to ensure current awareness of status of applicable systems at all times.
- Maintain a database of CSV tasks.
- Liaise with System Owners to maintain the computerised systems in a validated status at all times.
- Review and approval of proposed and executed changes in MasterControl for CSV related projects (e.g., new system implementations, major upgrades).
- Engage in the 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).
- 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.
- Communicate with the CSV team, System Owners and the DQA.
- Active member of the Avance CSV Committee / minute taker during routine CSV Committee meetings.
- Ensure regulatory requirements are applied and adhered to as applicable throughout the CSV life cycle of regulated systems.
- Perform CSV activities as per Avance SOPs.
- Conduct internal process audits to verify compliance with internal processes and applicable regulatory requirements.
- Assist with vendor audits and audits conducted by sponsors.
- As required, contribute as a member of the investigational team for CAPAs.
- Coordinate preparation, review and issue of Standard Operating Procedures (SOPs) to support and maintain Avance Clinicals’ quality systems and/or validation procedures.
- Maintain an up-to-date knowledge of the latest requirements relating to CSV and GCP and regulatory requirements in Australia and overseas.
- Other duties as directed by Line Management or delegate.

**Qualifications, Skills and Experience**
- Bachelor’s degree (preferably in a science 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 training or evidence based internal / study audit training.
- 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 work in, and be supportive of, a positive and dynamic team culture.
- Intermediate MS Office suite.
- Experience using MasterControl is desirable, but not essential.
- Knowledge of GAMP 5 is preferred.

**What we offer**
- Stimulating work
- Project diversity
- An intellectual challenge
- An agile & flexible workplace
- Opportunity to progress
- Stability
- Sense of community
- A leadership team that are working together on a common goal
- Flexible work options - you can be based from home
- Great tools / tech to do your job
- A competitive salary & an extra days holiday for your