Quality Assurance Manager

1 week ago

Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

**About Aegros**

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 collected into life saving hyperimmune products.

**About the role**

We are seeking an experienced person to join our quality control and assurance team to perform a range of tasks including:

- Perform full spectrum of QA functions and audits.
- Set-up and maintain QMS.
- Ensure QMS and operational compliance with regulatory requirements.
- Lead for key QMS systems such as audits, CAPA, SOP review, etc.
- Support RA activities.
- Set-up and maintain QMS.
- Lead in developing and implementing quality strategies.
- Evaluates production capabilities and recommend improvements.
- Deviation and compliant management, Products and Materials Release, Validation and Change Control Support, New production introduction and Documentation Controls to ensure an efficient operational Quality System that assures full compliance with company policies, regulatory requirements and cGMP
- Responsible for ensuring that material supplied is fit for purpose for customer
- Responsible for providing quality oversight for Operations activities
- Ensure the effectiveness of investigations and to make decisions on the adequacy of investigations, root cause analysis and corrective and preventive actions
- Ensure inspection readiness of the area with respect to all internal and external audits. When required provide responses and timely follow up on relevant corrective actions and commitments made as a result of the inspections, communicating with TGA, FDA and other regulatory agencies concerned if necessary.
- Provide support/guidance for the implementation and maintenance of corporate and cGMP standards.
- Any additional duties as assigned.

**Requirements**:
To be the successful applicant for this great opportunity you will have:

- a minimum of Bachelor of degree in Life Sciences (Chemistry, Microbiology, etc.) or equivalent,
- a minimum of 3 years’ experience in managing and conducting Quality Assurance / Quality Management System functions in Pharmaceutical / Biopharmaceutical industry within Australia and Internationally,
- preferably with experience in cGMP working environment, start-ups, commissioning and qualification of process equipment in an operating plant;
- Professional membership with Quality Assurance organization is beneficial.

**Benefits**
- Supportive and friendly team
- Rewarding culture
- Weekly Fruits
- Birthday Celebration

  • Quality Assurance Manager

    2 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    About Aegros 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...

  • Quality Assurance Associate

    2 weeks ago

    Macquarie Park, Australia MSD Full time

    **Quality Assurance Associate** - ** Looking for a different challenge as a** Quality Assurance Associate**whereby you can still utilise your skills? - ** Permanent, Full-time**position with **competitive renumeration**and** benefits**: - Role based **Macquarie Park, Sydney, Australia**: - ** Hybrid, work from home and office environment**, with a...

  • Quality Assurance Associate

    2 weeks ago

    Macquarie Park, Australia MSD Full time

    **Associate Specialist, Quality Assurance** - ** Looking for a different challenge as a** Associate Specialist, Quality Assurance **whereby you can still utilise your skills? - ** 1 year Fixed Term Contract, Full-time **position with **competitive renumeration **and** benefits** - Hybrid, work from home and office environment, with a **dedicated and...

  • Quality and Assurance Manager

    4 days ago

    Arndell Park, Australia Ventia Pty Limited Full time

    Ventia aspires to provide a step-change in the delivery of road and Intelligent Transport Systems maintenance and management services through the Sydney Roads Asset Performance Contract. The Sydney Roads Asset Performance Contract is a venture which will undertake the delivery of maintenance excellence to improve the lives of customers and communities,...

  • Quality Assurance Manager

    1 week ago

    Norwest Business Park, Australia Greenstone Full time

    **Quality Assurance Manager** **Full-Time** - **Are you passionate about leadership, developing people and ready to take on a new challenge?**: - **Are you an analytical thinker with a flare for innovation and process improvement?**: **We are currently seeking a passionate Quality Assurance Manager, responsible for leading, coaching and mentoring the...

  • Quality Assurance Manager

    2 weeks ago

    Arndell Park, Australia BE Campbell Full time

    Lead an experienced valued team to deliver wholesome, quality food produc - Work with a very supportive Operations Team - Attractive and competitive renumeration package **About the Role** We're actively seeking an experienced Quality Assurance Manager to join our dynamic technical team in Arndell Park. In this role, you'll be responsible for overseeing...

  • Quality Assurance Manager

    1 week ago

    Arndell Park, Australia Picasso foods Australia Pty Ltd Full time

    We are seeking an experienced and driven **Quality Assurance Manager** to join our team. This pivotal role is responsible for leading food safety, quality systems, and compliance across our operations, and reports to the Head of Technical and Quality. **Key Responsibilities** **1. Quality Systems & Compliance** - Manage and maintain the Food Safety and...

  • Quality Assurance Manager

    6 days ago

    Osborne Park, Australia Il Granino Bakery Full time

    Leymor Pty Ltd ATF Ciabatta Unit Trust T/A IL Granino Bakery Osborne Park, Perth WA Quality Assurance & Control (Manufacturing, Transport & Logistics) Full time $90,000 - $100,000 per year Posted 30d+ ago Quality Assurance Manager Il Granino Bakery is a WA-owned artisan bakery, producing a wide range of specialty bread products, croissants, muffins,...

  • Quality Assurance

    1 week ago

    Buckland Park, Australia P'Petual Holdings Full time

    Ensure the completion of necessary documents for all quality assurance activities. - Responsible for managing all work according to order schedule and completion of all orders within the time frame - Monitor and evaluate produce, reporting any quality issues - Responsible for order packing accuracy & traceability (quality, best before dates, labelling etc) -...

  • Quality Assurance Investigator

    4 days ago

    Macquarie Park, Australia AstraZeneca Full time

    **Quality Assurance Investigator** We are seeking experienced QA Associates, with experience in investigations to join the Quality - validation team. - Two exciting 12 months Fixed term Full-time opportunities - Utilise and promote Human and Organisation Performance attitudes to support the building of systems that are error tolerant. - Be part of a culture...