QA Manager
7 months ago
Global Pharmaceutical Manufacturing Organisation
- Long Term Opportunity - Major New Global Project
- Melbourne Metro - Hybrid Based Role
**About the Organisation**
As a renowned & passionate International Leading Global Manufacturer of pharmaceutical and health care products worldwide, our client is now seeking a
**QA Manager with CSV/Digital execution systems experienc**e to work for major new project work on a global basis.
**About the Opportunity**
Reporting to the Senior Quality Manager, key duties include the following:
- Support & liaise with digital quality team supporting engineering. quality & vendors for major project needs.
- Provide compliance & validation experience in automation & engineering.
- Participate in project team activities with respect to validation of CSV systems.
- Review validation plans, risk assessments, validation deliverables for computer systems.
- Review GxP documentation ensuring compliance with execution systems controlling manufacturing (MES) systems.
- Effectively liaise internally with digital quality, engineering, quality & external vendors.
**About Your Skills & Experience**:
- Tertiary Qualifications in IT Systems, Engineering or Science.
- Specific experience in pharmaceutical/medical device industries.
- Exposure to Computer Systems Validation (CSV) within a regulated FDA environment.
- Sound experience in project management principles
- Strong technical & analytical skills.
- Excellent communication & interpersonal skills.
- Great Team Player with ability to develop strong stakeholder relationships.
**Culture & Benefits**
This is a Challenging & Excellent Opportunity for a
**QA Manager with Digital Execution Systems with sound CSV (Computer Systems Validation) experience and a strong pharmaceutical** background to be involved in major projects within this leading global pharmaceutical organisation.
**This Excellent Local & Global Opportunity requires an Immediate start.**
**How To Apply**
For further discussion, please contact Sue Campbell on 0471 994 917 or Maria Julienne on 0491 694 371.
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