Senior Associate Pharmaceutical Quality Assurance
vor 4 Wochen
We are looking for an experienced Senior Associate Quality Assurance (QA) to join the CSL Behring Quality team based at Broadmeadows (Australia) on a fixed term basis until 31 July 2025 (maternity leave replacement). Reporting to the Manager QA Value Stream Release, you will review batches of intermediate, semi-finished and finished product and authorise their release. You will also help review quality issues related to post-release actions including Product Technical Complaints (PTC) and Adverse Event Investigations (AE).
The RoleBased onsite at Broadmeadows and working with a diverse team, you will:
- Review the relevant product portfolio batch / release documentation to ensure that intermediates and final product are suitable for further processing or release and report any issues identified;
- Perform detailed review of batch records for starting materials, intermediate and final products;
- Perform batch dispositions of plasma, intermediates, and semi-finished including completing SAP transactions and preparing documentation required;
- Coordinate PTC investigations and Adverse events to identify the root-cause and appropriate corrective and preventive actions;
- Participate in internal inspections and regulatory inspections to support compliance requirements;
- Perform SAP master data management for QA release;
- Provide training to value stream production partners;
- Work with other Quality teams across the network in Batch Release to improve and standardise the quality processes and standards.
To be considered for this role you have:
- A Bachelor's Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience;
- 5+ years' experience working in a similar role in pharmaceutical manufacturing or other regulated manufacturing industry;
- 3+ years experience working with GxP and local and international regulatory requirements i.e. TGA and FDA;
- Experience making risk based quality decisions with relevant justifications;
- Experience in TrackWise or Veeva and electronic document management systems (eDMSs);
Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-231311 by 19 May 2024.
#LI-Onsite
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .
We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
We are looking for an experienced Senior Associate Quality Assurance (QA) to join the CSL Behring Quality team based at Broadmeadows (Australia) on a fixed term basis until 31 July 2025 (maternity leave replacement). Reporting to the Manager QA Value Stream Release, you will review batches of intermediate, semi-finished and finished product and authorise their release. You will also help review quality issues related to post-release actions including Product Technical Complaints (PTC) and Adverse Event Investigations (AE).
The RoleBased onsite at Broadmeadows and working with a diverse team, you will:
- Review the relevant product portfolio batch / release documentation to ensure that intermediates and final product are suitable for further processing or release and report any issues identified;
- Perform detailed review of batch records for starting materials, intermediate and final products;
- Perform batch dispositions of plasma, intermediates, and semi-finished including completing SAP transactions and preparing documentation required;
- Coordinate PTC investigations and Adverse events to identify the root-cause and appropriate corrective and preventive actions;
- Participate in internal inspections and regulatory inspections to support compliance requirements;
- Perform SAP master data management for QA release;
- Provide training to value stream production partners;
- Work with other Quality teams across the network in Batch Release to improve and standardise the quality processes and standards.
To be considered for this role you have:
- A Bachelor's Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience;
- 5+ years' experience working in a similar role in pharmaceutical manufacturing or other regulated manufacturing industry;
- 3+ years experience working with GxP and local and international regulatory requirements i.e. TGA and FDA;
- Experience making risk based quality decisions with relevant justifications;
- Experience in TrackWise or Veeva and electronic document management systems (eDMSs);
Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-231311 by 19 May 2024.
#LI-Onsite
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .
We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
#J-18808-Ljbffr-
Melbourne, Österreich CSL VollzeitSenior Associate Pharmaceutical Quality Assurance Batch ReleaseWe are looking for a full-time Senior Associate, Quality Assurance (QA) Batch Release to join our diverse QA team in Parkville (Australia). This is a fixed term position until 31 August 2025. You will support the batch release of products, ensure ongoing compliance with domestic and international...
-
Senior Quality Assurance Associate
vor 1 Monat
Melbourne, Österreich DBG Health VollzeitThis is a fantastic opportunity to get a foot in the door with a rapidly expanding business that could lead to an exciting new career with Arrotex! 10th May, 2024 Arrotex Pharmaceuticals is seeking a highly motivated and detail-oriented Senior Quality Assurance Associate to join our dynamic Scientific Affairs team. The Senior Quality Assurance Associate...
-
Senior Quality Assurance Associate
vor 4 Wochen
Melbourne, Österreich DBG Health VollzeitThis is a fantastic opportunity to get a foot in the door with a rapidly expanding business that could lead to an exciting new career with Arrotex! 10th May, 2024 Arrotex Pharmaceuticals is seeking a highly motivated and detail-oriented Senior Quality Assurance Associate to join our dynamic Scientific Affairs team. The Senior Quality Assurance Associate...
-
Quality Assurance Lead
vor 1 Monat
Melbourne, Österreich CHR Life Sciences VollzeitCHR Life Sciences is excited to be partnered with a growing business operating across all the GxPs providing a turnkey (end-to-end) solution to clients by offering support throughout the product life cycle and manufacturing process. They are passionate about patient safety and welfare, and genuinely care for clients and provide them with the highest...
-
Quality Assurance Lead
vor 4 Wochen
Melbourne, Österreich CHR Life Sciences VollzeitCHR Life Sciences is excited to be partnered with a growing business operating across all the GxPs providing a turnkey (end-to-end) solution to clients by offering support throughout the product life cycle and manufacturing process. They are passionate about patient safety and welfare, and genuinely care for clients and provide them with the highest...
-
Senior Quality Assurance Manager
vor 2 Wochen
Melbourne, Österreich MetLife VollzeitMetLife is a leading global life insurer, and the insurance partner for Hostplus, one of Australia’s largest and fastest growing superannuation fund with over $100bn in assets and over 1.8 million members. MetLife have created a market-first service experience for Hostplus that delivers market-leading support and guidance for members for any insurance...
-
Quality Assurance Lead
vor 1 Monat
City of Melbourne, Österreich CHR Life Sciences VollzeitCHR Life Sciences is excited to be partnered with a growing business operating across all the GxPs providing a turnkey (end-to-end) solution to clients by offering support throughout the product life cycle and manufacturing process. They are passionate about patient safety and welfare, and genuinely care for clients and provide them with the highest...
-
Quality Assurance Lead
vor 4 Wochen
City of Melbourne, Österreich CHR Life Sciences VollzeitCHR Life Sciences is excited to be partnered with a growing business operating across all the GxPs providing a turnkey (end-to-end) solution to clients by offering support throughout the product life cycle and manufacturing process. They are passionate about patient safety and welfare, and genuinely care for clients and provide them with the highest...
-
Quality Assurance Officer
Vor 2 Tagen
Melbourne, Österreich Pact Group VollzeitJob Title: Quality Assurance OfficerPact Group in Melbourne, VIC, Australia is seeking a Quality Assurance Officer to support the company's sustainable packaging initiatives. Responsibilities include:Conducting auditsQuality inspectionsTestingReporting out-of-spec resultsImplementing corrective actionsTraining employeesQualifications include a minimum of 2...
-
Quality Assurance Officer
vor 2 Wochen
Melbourne, Österreich Pact Group VollzeitJob Title: Quality Assurance Officer Pact Group in Melbourne, VIC, Australia is seeking a Quality Assurance Officer to support the company's sustainable packaging initiatives. Responsibilities include: Conducting audits Quality inspections Testing Reporting out-of-spec results Implementing corrective actions Training employees Qualifications include a...
-
Quality Manager
vor 2 Wochen
Melbourne, Österreich Pact Group VollzeitPact's APM Contract Manufacturing division manufactures and packs for nutraceutical, herbal, vitamin, mineral and nutritional supplements. Tablets, hard capsules and powdered products are produced in our in our state of the art, TGA compliant facility in Keysborough.Our uniquely flexible and purpose-built facilities utilise the latest blending, granulating...
-
Claims Quality Assurance Specialist
Vor 3 Tagen
Melbourne, Österreich TAL VollzeitFrom the millions of Australians we protect, to those that make it happen every day at TAL, people really are what we’re all about.We want to grow with you. Achieve with you. And support you to do your best work. That's why we're focused on developing leadership, promoting diversity, rewarding excellence, and retaining great talent.We're always looking for...
-
Quality Assurance Coordinator
vor 3 Wochen
Melbourne, Österreich Asahi Beverages VollzeitApply now Job no: 502119 Work type: Fixed Term - Full Time Location: Melbourne Categories: Manufacturing/Operations Your ImpactEmbark on a compelling journey as a proactive and dynamic Quality Assurance Coordinator at our Laverton facility, where innovation and excellence define our commitment to quality. Reporting directly to the Quality Manager, you...
-
Quality Assurance Coordinator
vor 2 Wochen
Melbourne, Österreich Asahi Beverages VollzeitApply now Job no: 502119 Work type: Fixed Term - Full Time Location: Melbourne Categories: Manufacturing/Operations Your ImpactEmbark on a compelling journey as a proactive and dynamic Quality Assurance Coordinator at our Laverton facility, where innovation and excellence define our commitment to quality. Reporting directly to the Quality Manager, you...
-
Quality Assurance Engineer
vor 1 Monat
City of Melbourne, Österreich Farm Credit Services Vollzeit**Hybrid-Position is required to work a minimum of three days each week in the Omaha, NE office**Farm Credit Services of America (FCSAmerica) is a great place to work. You see it in our people and the relationships they have with each other and our customers. Our passion and commitment to serving both rural America and each other is key to our success in the...
-
Quality Assurance Engineer
vor 4 Wochen
City of Melbourne, Österreich Farm Credit Services Vollzeit**Hybrid-Position is required to work a minimum of three days each week in the Omaha, NE office**Farm Credit Services of America (FCSAmerica) is a great place to work. You see it in our people and the relationships they have with each other and our customers. Our passion and commitment to serving both rural America and each other is key to our success in the...
-
Quality Assurance Manager
vor 1 Monat
Melbourne, Österreich Hostplus Pty VollzeitHow will you make an impact?Are you driven by the desire to create a positive difference in the lives of our members?In this role, you will be instrumental in establishing and upholding our quality assurance program within the insurance claims team and providing our members with an exceptional level of customer service when managing their super.The...
-
Quality Assurance Manager
vor 4 Wochen
Melbourne, Österreich Hostplus Pty VollzeitHow will you make an impact?Are you driven by the desire to create a positive difference in the lives of our members?In this role, you will be instrumental in establishing and upholding our quality assurance program within the insurance claims team and providing our members with an exceptional level of customer service when managing their super.The...
-
Clinical Quality Assurance Manager
vor 1 Monat
Melbourne, Österreich Hapi Healthcare UK Limited VollzeitAs a Quality Assurance Manager, you will assume operational oversight for clinical quality of care and champion maintenance of highest standards. 22nd April, 2024 HAPI HEALTHCARE - AN INTUITIVE DIGITAL HEALTH COMPANY Empowering people to live Hapi'er healthier livesA Hapi Opportunity: Melbourne, VICAs a Quality Assurance Manager you will oversee a...
-
Junior Regulatory Affairs Associate
vor 53 Minuten
Melbourne, Österreich DBG Health VollzeitThis is a great opportunity to get your foot in the door with a market leading pharmacentical organisation 25th June, 2024 Junior Regulatory Affairs Associate DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 800 dedicated professionals, we are committed to delivering affordable and...
