Computer Systems Validation Specialist - Melbourne, Victoria Australia - 17229

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Job #: 17229
Title: Computer Systems Validation Specialist
Job Location: Melbourne, Victoria - Australia
Employment Type:
Salary: $95,000.00 - $110,000.00 - Australian Dollars - Yearly
Employer Will Recruit From: Worldwide
Relocation Paid?: NO


Excellent Opportunity to join global pharmaceutical company for Computer Systems Validation Specialist work. 

Candidate must have 21 CFR Part 11 and GAMP experience within the pharmaceutical industry. 


About the company

Operating as a leading global multinational manufacturer our client is one of the world’s leading global pharmaceutical manufacturers renowned for its worldwide innovative technologies and research and development programs.

Due to new project requirements, an opportunity has arisen for a talented & experienced Computer Systems Validation Specialist with specific experience in GAMP and with 21 CFR Part 11 to join their group for major project validation work on local and global projects.

About the Opportunity

Reporting to the Senior Quality Manager, key duties include the following:

  • Define validation strategies for computerised systems, maintain & support IT Quality related process such as change management, defect management and IT document management.
  • Be responsible for validation activities including reviewing & approving validation documentation for laboratory instruments that meet 21 CFR Part 11 compliance.
  • Review & advise project validation documentation for local & global projects that meets all GAMP regulations and requirements for the both Europe and the USA. 
  • Review all quality relevant documents that support cGxP especially Annex 11, 21 CFR Part 11 on computerised systems.
  • Review various regulatory risk assessments & protocols in relation to computer system validation practices.

About you

The successful candidate will have the following skills & experience: 

  • Tertiary Qualifications in IT computer systems, electronics or communications engineering or a related disciplined.
  • Sound knowledge of cGxP especially Annex 11, 21 CFR Part 11 on computerised systems.
  • Sound understanding of computerised systems validation processes within the pharmaceutical industry & an understanding of GAMP principles.
  • Sound understanding of IT Quality Management systems & principles.
  • Strong technical & analytical skills with the ability to manage complexities.
  • Excellent communication & well developed interpersonal skills with ability to be able to liaise at all levels within an organisation.

Culture & Benefits

This is a challenging & excellent opportunity for a talented individual with sound computer systems validation (CSV) experience to join this leading global pharmaceutical organisation to further develop their skills & experience within CSV & be involved in a variety of local & global projects, working with likeminded people in a culturally diverse environment.  An attractive salary remuneration & benefits will be offered to the successful candidate.


Bachelor of Science or Bachelor of Engineering or Bachelor or Computing 

University - Bachelor's Degree/3-4 Year Degree