Quality Assurance Manager



Work type:

Full Time


Information & Communication Technology


$100000.00 - $114000 per annum

Job reference:


Start date:


Contact email:


Melissa Haddah

The Opportunity
We have an permanent opportunity for a Business Technology Quality Management Delegate (BT QMD) to be the individual delegated by Quality Assurance (QA) to perform designated QA functions that relate to computer systems (i.e. Computer System Validation or CSV). As the first contact for internal and external inspections, you will support GxP deviation handling and the review of quality relevant documents.

The position holder defines validation strategies for computerized systems, maintains and supports IT quality related processes as change management, defect management and IT document management.Reporting to the Senior Manager BT Quality Australia, you will be:
* Responsible for reviewing and approving project validation documents for local and global projects for compliance with European, Asia-Pacific and US regulatory requirements as well as with internal standards and procedures.
* Responsible for leading, advising, supporting and instructing validation responsible during global and local projects.
* Providing approval of systems for productive use (together with Quality Assurance and the Process Owner)
* Developing the BT QMS through the creation of SOPs, templates and other internal quality guidelines and specifications.
* Coordinating ongoing development measures with QA under consideration of American, European, Asia and Australian regulatory requirements.
* Responsible for creating training documents and executing BT training sessions
.* Providing support and advice during the creation and administration of training plans.
* Responsible for the review and approval of changes for all systems (incl. infrastructure) with varying levels of complexity.
* Responsible for processing BT deviations according to SOP
.* Preparing, assisting and following-up audits with the area of responsibility.
* Responsible for conducting assessments of BT suppliers (possibly in cooperation with QA)
.* Acting as Validation Responsible to generate CSV deliverables.

To be successful you require:
* Bachelor's degree or equivalent experience; educational concentration in IT, computing, engineering or a related discipline is preferred. Post graduate qualifications in business is desirable but not essential
* 5+ years of experience working within IT or within an applicable function that directly aligns with the specific responsibilities for this position.
* Computer Systems auditing
* Ability to negotiate with peers and management* Effectively liaise with BT, the business and QA* Ability to effectively train others
* Understanding of IT Quality Management Systems and Principles
* Knowledge of cGxP, especially Annex 11, 21CFR Part 11 on Computerized systems
* Knowledge of computerized systems' validation practices
* Knowledge of GAMP and the corresponding regulations and guidelines (Europe, Asia-Pacific and USA)
* Project Management

If this sounds like you Apply now or email or call on (03) 9236 7732

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