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Digital Quality QA Manager

QA Manager – Execution Systems

Position Location: Tullamarine and Broadmeadows

Planned Start Date: November for 12 months – possibility of extension


Position Purpose:
As a QA Manager – Execution Systems, your role is essential in ensuring the quality and compliance of computerized systems in the pharmaceutical industry, particularly those subject to GxP regulations. You will collaborate with cross-functional teams to ensure adherence to FDA regulations and foster a culture of compliance and validation within the automation and engineering space. Your ideal candidate profile includes pharmaceutical industry experience.

Must-Haves:

Exposure to computer system validation.
Practical knowledge of FDA regulations.
Experience in a regulated space.
Strong background in compliance and validation, particularly in the automation and engineering space.
A collaborative team player, able to contribute to problem-solving.
Pharmaceutical industry experience is highly desirable.

Role:

In this role, you will be responsible for:
GxP compliance oversight of execution systems and automation systems, which control manufacturing systems in the plant.
Supporting the current Full-Time Equivalent (FTE) in the digital quality team.
Collaborating with digital quality, Banksia quality, engineering quality, and vendors to ensure the smooth validation of systems.
Reviewing validation plans, risk assessments, and validation deliverables for computer systems.

Location: Tullamarine and Broadmeadows

Team Size:

The local digital quality team consists of one person, but there are three others in the broader team. Globally, additional team members contribute to the initiative.

Flexibility:

In the initial months, a stronger on-site presence will be necessary to gain a comprehensive understanding of the role. However, an ongoing preference for on-site work will be balanced with some flexibility.
Hours:

Standard hours are Monday to Friday, but given the project nature, flexibility in working hours may be required.

Overtime Compensation:

If the person works more than 38 hours in a week, they will be compensated for hours worked.

Potential to Extend:

Yes, there is the potential for the role to be extended based on performance and project needs.
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