CSV & Quality Specialist

2 hours ago

Melbourne, Victoria, Australia PQE Group Full time $80,000 - $120,000 per year

Are you ready to join a
world leader
in the exciting and dynamic fields of the
Pharmaceutical and Medical Device industries
?
PQE Group
has been at the forefront of these industries
since 1998
, with
40 subsidiaries
and more than
2000 employees in Europe, Asia and the Americas
.

Due to our continuous growth, PQE Group is seeking an experienced
CSV & Quality Specialist
to support validation and quality oversight activities for a large automation and digital systems upgrade within a GMP manufacturing environment. While the role includes elements of Quality Assurance, the
primary focus
will be on
Computer System Validation (CSV)
across various project phases. The position will also provide support to selected activities in an additional systems implementation workstream.

Responsibilities include, but are not limited to:

  • Lead
    and support
    Computer System Validation
    activities for a major automation and digital systems upgrade within a GMP environment.
  • Review
    and approve validation documentation, including URS, risk assessments, validation plans, test protocols, traceability matrices, and reports.
  • Support and participate in
    qualification activities
    such as FAT, SAT, IQ, OQ, and PQ.
  • Ensure compliance with
    GxP expectations
    and data integrity principles.
  • Provide technical guidance on
    system lifecycle management
    and validation strategy.
  • Offer QA oversight for system-related documentation, change controls, deviations, and project deliverables.
  • Support
    audit readiness
    and ensure project activities adhere to quality and compliance requirements.
  • Collaborate with
    cross-functional teams
    to ensure timely and compliant execution of CSV and QA activities.

Required Qualifications:

  • Degree
    in Engineering, Life Sciences, Computer Science, or a related discipline.
  • Demonstrated experience in
    Computer System Validation
    within a GMP-regulated environment.
  • Solid understanding of
    QA processes
    and GxP regulations.
  • Experience supporting complex
    system implementation
    or digital transformation projects.
  • Strong analytical, documentation, and communication skills.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a
challenging, multicultural company that values collaboration and innovation
. PQE Group gives you the
opportunity to work on international projects
, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a
rewarding and exciting career
, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.

  • New Business Manager

    1 week ago

    Melbourne, Victoria, Australia AMP Full time $90,000 - $120,000 per year

    DescriptionIf you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking. For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something...

  • NSC Consultant

    1 week ago

    Melbourne, Victoria, Australia AMP Full time $60,000 - $90,000 per year

    If you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking.For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something even more...

  • Platform Developer

    1 week ago

    Melbourne, Victoria, Australia AMP Full time $100,000 - $180,000 per year

    DescriptionIf you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking. For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something...

  • NSC Claims

    1 week ago

    Melbourne, Victoria, Australia AMP Full time $104,000 - $170,000 per year

    DescriptionIf you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking. For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something...

  • Staff Engineer

    6 days ago

    Melbourne, Victoria, Australia Culture Amp Full time $120,000 - $180,000 per year

    Join us on our mission to make a better world of work. Culture Amp is the world's leading employee experience platform, revolutionizing how 25 million employees across more than 6,500 companies create a better world of work. Culture Amp empowers companies of all sizes and industries to transform employee engagement, drive performance management, and develop...

  • Staff Engineer

    5 hours ago

    Melbourne, Victoria, Australia Culture Amp Full time $120,000 - $180,000 per year

    Join us on our mission to make a better world of work.Culture Amp is the world's leading employee experience platform, revolutionizing how 25 million employees across more than 6,500 companies create a better world of work. Culture Amp empowers companies of all sizes and industries to transform employee engagement, drive performance management, and develop...

  • Lead Business Analyst

    1 week ago

    Melbourne, Victoria, Australia AMP Full time $120,000 - $180,000 per year

    DescriptionIf you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking. For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something...

  • Platforms Tax and Accounting Manager

    4 hours ago

    Melbourne, Victoria, Australia AMP Full time $120,000 - $180,000 per year

    DescriptionIf you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking. For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something...

  • Platforms Tax and Accounting Manager

    2 hours ago

    Melbourne, Victoria, Australia AMP Full time $120,000 - $180,000 per year

    If you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking.For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something even more...

  • NSC Transactions Manager

    1 week ago

    Melbourne, Victoria, Australia AMP Full time $120,000 - $150,000 per year

    If you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking.For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something even more...