Sydney Digital Advisory is a consultancy firm that provides expert advisory and consulting services to Government agencies and Small to Medium Enterprises. With nearly two decades of experience serving Billion Dollar Global Corporations and Fortune 50 companies, our consultants offer World Class Expertise in Management Consulting, Digital Transformation, Architecture Consulting, and more. Our mission is to create relationships, not transactions, through transparent communication and expert collaboration to boost your bottom line.

We are seeking a seasoned Computer Systems Validation Analyst, ideally having 10-15 years of experience in the CSV space. The purpose of this role is to ensure health authority regulated computer systems are implemented in accordance and compliance with the relevant regulatory code (PIC/S, FDA CFR) and following industry standard guidelines (GAMP). Reporting to the IT Project Manager, the role will be self-driven and will work with the Lead CSV Specialist to provide planning and to support the IT group and business in IT projects that require CSV activities. This position is open to Australian Citizens with ability to obtain a security clearance.

Role Responsibilities

1. Create and support the creation of Organisation’s validation artefact; including but not limited to:

a. Validation Master Plan

b. User Requirement Specification

c. Functional Risk Assessment

d. Validation Summary report

e. System Configuration Specification

f. GxP Impact Statement

g. Functional Specification / Design Specification

h. CSV protocols (IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements

i. Requirements Traceability Matrix

2. Facilitate and conduct functional risk assessments.

3. Plan and execute validation activities (Prospective and Concurrent Validation).

4. Ensure all regulated systems are maintained in a validated state throughout the life cycle of the system.

5. Facilitate and train stakeholders on computer systems validation.

6. Liaise with Vendors and provide ongoing support/participate in QA activities.

7. Responsible for preparing and executing test documentation for GMP computerised systems as well as providing support in the troubleshooting of issues during test execution with good understanding of 21 CFR Part 11, FDA (GxP) regulations, and GAMP methodologies.

Qualifications

1. Knowledge in GAMP 5 and the System Development Life Cycle (SDLC) in a pharmaceutical environment

2. Exposure to a Good Manufacturing Practice (GMP) environment and understanding of PIC/S and FDA regulatory code (Annex 11 and 21 CFR Part 11)

3. Sound understanding of CSVMP policies, procedures, and templates; and coach the project teams on using the correct processes and best practice.

4. Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with different level of stakeholders

5. Experience in Good Documentation Practices (GDP)

6. Demonstrated experience in developing documents related to computer validation activities throughout the System Development Life Cycle (SDLC)

7. Demonstrated experience in developing and executing test protocols (qualification protocols) for computerised systems.

8. Experience with Quality Change Control is desirable

9. Experience in technical writing in validation and QMS documentation.

10. Extensive experience in Computer System Validation (CSV) and quality management of multiple IT systems in a highly regulated environment.

11. Strong communication and Stakeholder & Vendor engagement.

12. Tertiary qualifications in Engineering or Science discipline. Preferably in Computer Science/Information Technology.

13. Demonstrated technical IT aptitude for troubleshooting GMP IT implementations.

14. Eye for detail to ensure data integrity.