Computer Systems Validation Manager - Melbourne, Victoria Australia - 17479



JOB DESCRIPTION

Job #: 17479
Title: Computer Systems Validation Manager
Job Location: Melbourne, Victoria - Australia
Employment Type:
Salary: $115,000.00 - $125,000.00 - Australian Dollars - Yearly
Employer Will Recruit From: Worldwide
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


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

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

JOB DESCRIPTION

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 Manager 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 Director of Quality Systems, key duties include the following:

  • Lead, manage and mentor staff & consultants to complete work plan tasks and manage performance & potential.
  • Act as IT Quality & Validation Manager, define validation& qualification projects & provide support for computer system validation (CSV) activities.
  • Actively engage & consult with customers to develop systems to deliver enhanced products & services to the organisation’s customers.
  • In conjunction with key stakeholders, liaise with regulators & auditors to conduct both internal & vendors audits to ensure compliance with regulations.
  • Consolidate & develop customer focused quality management system using GMP principles within as ISO9001 framework.
  • Effectively liaise with customers of the organisation to provide a Quality Framework to oversee & ensure transparency, mitigation & escalation of risks.


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.
  • Extensive experience in IT Quality& Project Management within the pharmaceutical industry.
  • 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 leadership & management skills.
  • 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 management & leadership skills within the computer systems validation (CSV) area 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.

QUALIFICATIONS

Bachelor of Science or Bachelor of Engineering or Bachelor or Computing 

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

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