Head of Commissioning, Qualification

4 weeks ago

Brisbane, Australia Aegros Therapeutics Pty Ltd Full time

**Who we are**

Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.

At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.

Over 30 years we have developed our HaemaFrac process which enables countries to turn human plasma they collect into lifesaving hyperimmune products.

The Engineering Organisation is focused on the development of robust, innovative and at times disruptive solutions in a cross functional team environment which supports our companies’ objectives and the patients we serve.

**Here’s the high-level**

Reporting to the Chief Operating Officer Engineering, this position’s main purpose is the management of all Commissioning, Qualification, and Validation (**CQV**) activities to support our ongoing and future projects.

**Some of the key areas of focus and the why.**
- Lead strategic planning and development of activities for the companies CQV function.
- Ability to plan, develop and execute multiple fast track projects.
- Ensure systems, facilities and equipment meet design requirements.
- Ensure availability of resources to execute the projects to benchmark standard.
- Identify training opportunities for internal resources on the latest GMP guidelines and standards.
- Critically assess project risks and propose mitigations.
- Participate in regulatory inspections related to commissioning, qualification, and validation activities.
- Identify continuous improvement opportunities.
- Collaborate closely with senior leadership team in meeting organizational goals through establishing and reporting of department metrics.
- With the opportunity to start with the end in mind, help lead the evolution of our CQV processes.

**Requirements**:
**What I’m looking for**
- Educated to degree level in Architecture/Engineering.
- Minimum of 15+ years’ experience in process architecture within the pharmaceutical industry.
- Experience of working on large scale pharmaceutical projects at Management level.
- Well-developed interpersonal and communication skills.
- Flexibility to travel to Sydney if required

**Benefits**

**Here’s what I/we can offer you**
- An environment which allows the individual to grow alongside the company.
- A role that provides the bandwidth to explore innovative solutions while keeping patients at the centre of everything we do.
- The chance to work with global industry experts in an organisation where success will be defined not just on successful delivery of goals but on how they were achieved.
- A multicultural environment where every voice is heard.
- Comprehensive remuneration package including Bonus & Employee Share Options

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