Senior Associate- Frontline Qa

vor 2 Monaten

Melbourne, Österreich Csl Seqirus Vollzeit

Senior Associate- Frontline QA (Deviations) Apply locations: APAC, AU, Parkville, Seqirus
Time type: Full time
Posted on: Posted 2 Days Ago
Time left to apply: End Date: October 10, 2024 (5 days left to apply)
Job requisition id: R-243853
The Opportunity Are you passionate about ensuring product quality and compliance?
We're looking for an experienced Senior Associate, Frontline Quality Assurance (Deviations) to join our inclusive and dynamic team at Seqirus, Parkville (Australia).
Our Quality Assurance (QA) function plays a crucial role to help maintain the highest standards of quality and safety.
You will provide QA expertise to ensure compliance with the Quality System, cGMP, and regulatory guidelines and help investigate deviations and other quality issues.
You will also collaborate with colleagues across the site to provide QA advice for the smooth operation of quality processes and provide approval for breakdowns, maintenance works, and interventions that have the potential to affect product quality.
This is a fixed-term opportunity until December 2025. The Role Reporting to the Manager QA Frontline, you will: Review and approve deviations and CAPAs, ensuring compliance with global and site procedures and regulatory requirements. Perform quality impact assessments of deviations and other quality issues, ensuring risks are identified and minimized. Accomplish detailed root cause analyses, identify CAPAs, and determine product disposition to maintain the highest quality standards. Use your QA expertise to oversee shopfloor activities, ensuring quality is maintained across all business operations. Approve maintenance works and interventions that could impact product quality, safeguarding our standards. Implement continuous improvement projects to enhance product quality and operational efficiency. Prepare reports for the Product Quality Review (PQR) process, contributing to our ongoing quality assurance efforts. Review and approve GMP documents, ensuring all processes follow Good Manufacturing Practices. Your Experience To be considered for this role, you have:
A university degree in a relevant scientific discipline (Pharmacy, Chemistry, Microbiology, Biochemistry). 5+ years' GMP experience in pharmaceutical/biotech or other regulated industry. 3+ years' experience in deviations/investigations process and in a Quality Operations role within the pharmaceutical industry. Experience in Quality decision-making on the shopfloor (preferred). Familiarity with Regulatory Standards (TGA (PIC/S), FDA (CFR), and ISO-13485), Quality Risk Management, Quality Control, and Quality Assurance systems. Experience in a role requiring the communication of complex information, including technical writing, analysis, and accuracy. Knowledge of TrackWise, SAP, LIMS, and documentation management systems. How to Apply? Join us in shaping the future of quality assurance and making a difference in patients' lives.
Apply now and be part of our mission to deliver safe products to the world.
Please apply with your covering letter addressing your key selection criteria and your resume by 10th October 2024.
Our Benefits CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.
Learn more about some of the benefits you can participate in when you join CSL Seqirus.
About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL).
As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.
In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines.
Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion.
Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus Watch our 'On the Front Line' video to learn more about CSL Seqirus.
#J-18808-Ljbffr

  • Senior Account Executive, Frontline Solutions

    vor 1 Monat

    Melbourne, Österreich Tideri Jobbörse Vollzeit

    Senior Account Executive, Frontline Solutions goFLUENT is offering a unique opportunity for a B2B Senior Account Executive, Frontline Solutions selling to Fortune companies in the USA.The right candidate thrives on being part of a company that is fundamentally disrupting the language learning market.goFLUENT helps companies design a global language strategy...

  • Senior Account Executive, Frontline Solutions

    vor 1 Monat

    Melbourne, Österreich Gofluent Vollzeit

    Senior Account Executive, Frontline SolutionsgoFLUENT is offering a unique opportunity for a B2B Senior Account Executive, Frontline Solutions selling to Fortune companies in the USA. The right candidate thrives on being part of a company that is fundamentally disrupting the language learning market. goFLUENT helps companies design a global language strategy...

  • Senior Associate, Global Engineering Quality

    vor 1 Monat

    Melbourne, Österreich Csl Plasma Vollzeit

    The Opportunity: Join our dynamic team as a Senior Associate, Global Quality Engineering at CSL Behring Broadmeadows!In this pivotal role, you'll oversee quality for GMP capital projects, ensuring excellence in Technology Transfer, QbD, Commissioning and Qualification, Method Transfer and Validation, Process and Cleaning Validation, CPV, Stability, and...

  • Senior Associate, Global Engineering Quality

    vor 1 Monat

    Melbourne, Österreich Tideri Jobbörse Vollzeit

    The Opportunity: Join our dynamic team as a Senior Associate, Global Quality Engineering at CSL Behring Broadmeadows!In this pivotal role, you'll oversee quality for GMP capital projects, ensuring excellence in Technology Transfer, Qb D, Commissioning and Qualification, Method Transfer and Validation, Process and Cleaning Validation, CPV, Stability, and...

  • Senior Qa Analyst

    vor 1 Monat

    Melbourne, Österreich Digital Biz Solutions Vollzeit

    Senior QA AnalystDBiz Solution is a Transformational Partner. Digital transformation is intense. We'd like for you to have something to hold on to, whilst you set out bringing your ideas into existence. Beyond anything, we put humans first. This means solving real problems with real people and providing needs with real, working solutions.DBiz leverages a...

  • Senior Associate, Operational Services

    vor 4 Wochen

    Melbourne, Österreich Csl Plasma Vollzeit

    The Opportunity We are looking for a Senior Associate, Operational Services in our manufacturing Broadmeadows site.Reporting to the Manager Operational Services Visual Inspection and Packing, you will manage the implementation of routine changes in response to manufacturing value stream priorities and provide expertise in the facilitation and analysis of...

  • Senior Associate, Global Engineering Quality

    vor 1 Monat

    Melbourne, Österreich Csl Behring Vollzeit

    The Opportunity:Join our dynamic team as a Senior Associate, Global Quality Engineering at CSL Behring Broadmeadows! In this pivotal role, you'll oversee quality for GMP capital projects, ensuring excellence in Technology Transfer, QbD, Commissioning and Qualification, Method Transfer and Validation, Process and Cleaning Validation, CPV, Stability, and more....

  • Manager, Qa Compliance

    vor 1 Monat

    Melbourne, Österreich Csl Limited Vollzeit

    Quality Assurance & Control (Manufacturing, Transport & Logistics)Full timeJoin the CSL Behring Quality Assurance (QA) Compliance team on a full-time ongoing basis. CSL Behring Broadmeadows manufactures a comprehensive portfolio of 15 plasma products for Australia from plasma collected by Lifeblood Australia. Part of the CSL family, when you join the over...

  • Associate Or Senior Associate

    vor 1 Woche

    Melbourne, Österreich At Vollzeit

    Associate or Senior Associate - Disability & SuperannuationWe bring true purpose, authentic people and a proven path. You bring you.The OpportunityAs an Associate or Senior Associate in our Melbourne CBD-based disability and superannuation insurance practice, you'll be on the frontline as we doggedly seek justice. With compassion, connection and purpose,...

  • Senior Qa Analyst

    vor 1 Monat

    Melbourne, Österreich Digital Biz Solutions Vollzeit

    Senior QA Analyst DBiz Solution is a Transformational Partner.Digital transformation is intense.We'd like for you to have something to hold on to, whilst you set out bringing your ideas into existence.Beyond anything, we put humans first.This means solving real problems with real people and providing needs with real, working solutions.DBiz leverages a wealth...

  • Senior Qa Automation Engineer

    vor 1 Woche

    Melbourne, Österreich Ust Global Vollzeit

    Role description Senior QA Automation Engineer Lead I - Software Testing Who We Are: Born digital, UST transforms lives through the power of technology.We walk alongside our clients and partners, embedding innovation and agility into everything they do.We help them create transformative experiences and human-centered solutions for a better world. UST is a...

  • Senior Qa Analyst

    vor 1 Monat

    Melbourne, Österreich Tideri Jobbörse Vollzeit

    Senior QA Analyst DBiz Solution is a Transformational Partner.Digital transformation is intense.We'd like for you to have something to hold on to, whilst you set out bringing your ideas into existence.Beyond anything, we put humans first.This means solving real problems with real people and providing needs with real, working solutions.DBiz leverages a wealth...

  • Manager, Qa Compliance

    vor 1 Monat

    Melbourne, Österreich Tideri Jobbörse Vollzeit

    Quality Assurance & Control (Manufacturing, Transport & Logistics) Full time Join the CSL Behring Quality Assurance (QA) Compliance team on a full-time ongoing basis.CSL Behring Broadmeadows manufactures a comprehensive portfolio of 15 plasma products for Australia from plasma collected by Lifeblood Australia.Part of the CSL family, when you join the over...

  • Manager, Qa Compliance

    vor 1 Monat

    Melbourne, Österreich Csl Limited Vollzeit

    Quality Assurance & Control (Manufacturing, Transport & Logistics) Full time Join the CSL Behring Quality Assurance (QA) Compliance team on a full-time ongoing basis.CSL Behring Broadmeadows manufactures a comprehensive portfolio of 15 plasma products for Australia from plasma collected by Lifeblood Australia.Part of the CSL family, when you join the over...

  • Senior Qa Automation Engineer

    vor 1 Woche

    Melbourne, Österreich Ust Global Vollzeit

    Role descriptionSenior QA Automation EngineerLead I - Software TestingWho We Are:Born digital, UST transforms lives through the power of technology. We walk alongside our clients and partners, embedding innovation and agility into everything they do. We help them create transformative experiences and human-centered solutions for a better world.UST is a...

  • Senior Qa Engineer

    vor 1 Woche

    Melbourne, Österreich Ll Oefentherapie Vollzeit

    As a QA engineer, you will be helping to deliver a highly reliable, scalable, and performant service for the Aconex platform. You will be working with cutting-edge technologies and develop a deep understanding of various components and workflows. You will get involved in planning, refining requirements, and be closely working with other team members to...

  • Senior Qa Engineer

    vor 1 Woche

    Melbourne, Österreich Ll Oefentherapie Vollzeit

    As a QA engineer, you will be helping to deliver a highly reliable, scalable, and performant service for the Aconex platform. You will be working with cutting-edge technologies and develop a deep understanding of various components and workflows. You will get involved in planning, refining requirements, and closely working with other team members to perform...

  • Senior Qa Engineer

    vor 1 Woche

    Melbourne, Österreich Ll Oefentherapie Vollzeit

    As a QA engineer, you will be helping to deliver a highly reliable, scalable, and performant service for the Aconex platform.You will be working with cutting-edge technologies and develop a deep understanding of various components and workflows.You will get involved in planning, refining requirements, and closely working with other team members to perform...

  • Senior Qa Engineer

    vor 1 Woche

    Melbourne, Österreich Ll Oefentherapie Vollzeit

    As a QA engineer, you will be helping to deliver a highly reliable, scalable, and performant service for the Aconex platform.You will be working with cutting-edge technologies and develop a deep understanding of various components and workflows.You will get involved in planning, refining requirements, and be closely working with other team members to perform...

  • Associate Or Senior Associate

    vor 3 Wochen

    Melbourne, Österreich At Vollzeit

    Associate or Senior Associate - Disability & SuperannuationWe bring true purpose, authentic people and a proven path.You bring you.The Opportunity As an Associate or Senior Associate in our Melbourne CBD-based disability and superannuation insurance practice, you'll be on the frontline as we doggedly seek justice.With compassion, connection and purpose,...