Associate Sterility Assurance

6 months ago

Sydney, Australia Job Capital Full time

Our client is seeking an experienced Associate Sterility Assurance Officer

Reporting into the Sterility Assurance SME, the Associate / Senior Associate, Sterility Assurance will be

responsible for the oversight and life cycle management of Sterility Assurance controls governance, validation controls and monitoring controls at the site.

Work collaboratively with the Global SA team and Local SA team to provide a

holistic microbial contamination control strategy and improvement plan at our clients

Manufacturing site.
- Ensure appropriate development, implementation and maintenance of sterility

assurance standards and processes consistent with global governance, regulatory

requirements and industry standards (quality systems, policies, procedures and

work instructions).
- Collaborate with internal and external partners for the design of best practice

sterility assurance controls for the microbial contamination control strategy and life

cycle management - to deliver on time and to the required standards and

regulatory requirements with respect to sterility assurance controls, validation and

monitoring activities as directed by the Sterility Assurance SME or Site Leader
- Support local and global capacity expansion/new projects to ensure reliable supply

for our patients
- Support regulatory document submissions, internal and external (pre-approval and

routine) GMP inspections as directed by the Sterility Assurance SME or Site

Leader.
- Responsible for the generation of the documentation (IQ/OQ/PQ documents for

microbiological method validation (sterility testing, bioburden and endotoxin),

SOPs, risk assessments, trend reports, objectionable organism review, alert and

action in house limit review etc. to ensure compliance to GMP and that required

standards are met. Ensure a harmonized appearance of all documentation across

the global network.
- Support the local site in any deviations related to microbial contamination.
- Ensure that global standards are met for best practice

Training - Delivery of aseptic training and processes to value stream production partners

Education A minimum of a Bachelor Degree in Microbiology/Biology life sciences or equivalent

qualification or experience.

Experience - Demonstrated strong technical knowledge in the areas of sterility assurance of

aseptic cleanroom facilities, their processes and equipment, to include design,

validation and monitoring, life cycle management and cGMP compliance.
- Minimum +3/+5 (Associate/Senior Associate) years of experience in the

pharmaceutical manufacturing industry with direct experience in sterility assurance

of aseptic processing
- Extensive professional experience with respect to aseptic cleanrooms, processes,

equipment, validation, microbial monitoring, aseptic behaviors and gowning.
- Demonstrated experience in quality assurance and regulatory compliance with

GxP, FDA, EU and other regulatory agency guidelines.
- Experience in the manufacturing of biologics
- Direct experience executing Quality Assurance function and system within a

manufacturing and QC Microbiology/Sterility Assurance context.
- Experience in interacting with regulatory authorities including submissions and

inspections.
- Knowledge of auditing practices and procedures

**Job Types**: Full-time, Subcontract

**Salary**: $75,000.00 - $85,000.00 per year

**Benefits**:

- Visa sponsorship

**Education**:

- Bachelor Degree (required)

**Experience**:

- Relevant: 3 years (required)

Work Location: In person

  • Sterile Compounding Quality Assurance Specialist

    1 month ago

    Sydney, New South Wales, Australia Slade Health Full time

    About UsAt Slade Health, we are a well-established and respected industry name in the field of sterile compounding services. Our TGA licensed manufacturing facilities are based in Queensland, New South Wales, Victoria, and New Zealand. With over 50 years of experience in producing aseptically compounded pharmaceutical products, including chemotherapy,...

  • Sterile Compounding Quality Assurance Specialist

    3 weeks ago

    Sydney, New South Wales, Australia Slade Health Full time

    About UsSlade Health is a well-established provider of sterile compounding services, operating from its TGA licensed manufacturing facilities across Queensland, New South Wales, Victoria, and New Zealand.We have been producing aseptically compounded pharmaceutical products, including chemotherapy, analgesic, nutrition, and antibiotic drugs, for over 50 years...

  • Legal and Assurance Associate

    3 months ago

    Sydney, Australia Westpac Banking Corporation Full time

    Legal and Assurance Associate **Legal and Assurance Associate** - Permanent - Sydney - Use your Legal, Compliance, or Assurance background in a role that will make a difference **How will I help?** Join the Reward, Performance and Accountability team as a Legal & Assurance Associate in a role that will span the Westpac Group and make sure we have simple...

  • Senior Quality Assurance Specialist

    1 month ago

    Sydney, New South Wales, Australia Icon Group Full time

    Quality Assurance Specialist - Pharmaceutical CompoundingAs a key member of the Quality team at Icon Group, you will play a crucial role in ensuring the highest standards of quality in our pharmaceutical compounding services. Your primary responsibilities will include releasing compounded batches, participating in investigations and root cause analysis, and...

  • Legal and Assurance Associate

    3 months ago

    Sydney, Australia Westpac Group Full time

    **Legal and Assurance Associate** - Permanent - SydneyUse your Legal, Compliance, or Assurance background in a role that will make a difference **How will I help?** Join the Reward, Performance and Accountability team as a Legal & Assurance Associate in a role that will span the Westpac Group and make sure we have simple and efficient ways of working to...

  • Quality Assurance Associate

    6 months ago

    Sydney, Australia On Q Recruitment Full time

    Full time permanent role based in northwest Sydney - Flexible working arrangement of 3 to 4 days a week in the office - Unique opportunity to develop your skills in pharmacovigilance! - Full time permanent role based in northwest Sydney - Flexible working arrangement of 3 to 4 days a week in the office - Unique opportunity to develop your skills in...

  • Sustainability External Assurance

    7 months ago

    Sydney, Australia KPMG Full time

    Our ESG Advisory & Assurance (Sustainability) team work with organisations to help them manage the risks and opportunities associated with non-financial issues, and to enhance all aspects of reporting and communication. We also provide assurance services for overall non-financial disclosures to enhance the credibility of reported information. At KPMG we...

  • Sustainability Assurance Associate Director

    1 month ago

    Sydney, New South Wales, Australia KPMG Full time

    Job Description:The growing influence of non-financial issues, including environmental performance and social impact, is reshaping the business landscape, affecting financial performance and long-term business success for our clients and communities. As markets move towards a greater focus on Environmental, Social and Governance (ESG) risks, our Climate...

  • Associate Director

    4 weeks ago

    Sydney, Australia KPMG Full time

    The growing influence of non-financial issues, including environmental performance and social impact, is reshaping the business landscape, affecting financial performance and long-term business success for our clients and communities. As markets move towards a greater focus on Environmental, Social and Governance (ESG) risks, our Climate Change and...

  • Quality Assurance Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Icon Group Full time

    Pharmaceutical Quality Assurance Role in SydneyWe are seeking a highly skilled Quality Assurance Specialist to join our team in Sydney. As an integral member of our quality team, you will report to the Quality Pharmacist Supervisor and work closely with Operations to ensure that the compounding centre operates in compliance with regulatory and GMP...

  • Quality Assurance Associate

    6 months ago

    Sydney, Australia Icon Group Full time

    **Quality and Safety** **Sydney** **Full Time** **Slade Health** **Quality Assurance Associate - Slade Health** - Be Part of An Exciting Team working in a Dynamic and Supportive Work Environment - Play a key role in ensuring the compliant operation of a network of GMP Licensed compounding facilities, maintaining the overarching quality systems and...

  • Associate Director

    4 weeks ago

    Sydney, Australia KPMGau Full time

    Job DescriptionThe growing influence of non-financial issues, including environmental performance and social impact, is reshaping the business landscape, affecting financial performance and long-term business success for our clients and communities. As markets move towards a greater focus on Environmental, Social and Governance (ESG) risks, our Climate...

  • Project Assurance Specialist

    1 month ago

    Sydney, New South Wales, Australia Talenza Full time

    Project Assurance Analyst Role SummaryTalenza is seeking a skilled Project Assurance Analyst to join our team. As a key member of our EPMO, you will play a crucial role in ensuring the successful delivery of projects across our portfolio.Key Responsibilities:Provide assurance and oversight to project teams, ensuring they adhere to our Governance and Delivery...

  • Governance and Assurance Expert

    4 weeks ago

    Sydney, New South Wales, Australia Careerlink People Solutions Full time

    Senior Consultant – Governance and AssuranceThe RoleWe are seeking an experienced Governance and Assurance Senior Consultant to join our team at Careerlink People Solutions. This role requires a strong understanding of governance practices, compliance standards, and regulatory requirements.In this position, you will be responsible for developing and...

  • Quality Assurance Manager

    6 months ago

    Sydney, Australia HAYS Full time

    Sydney Metro - Quality Assurance Manager **Your new company** This is a unique and exciting opportunity to be part of the Health & Safety Team supporting the operation of the Metro North West Line and opening of the City Section on the Sydney Metro City & Southwest Project. The purpose of this role is to support safety, quality and assurance management...

  • Project Assurance Analyst

    1 month ago

    Sydney, Australia Talenza Full time

    Project Assurance Analyst - EPMO $150k base + 15.4% super Project assurance and delivery Financial Services background highly recommended Location: Sydney CBD + WFH About the Role: As Project Assurance Analyst - EPMO, you will provide project control and assurance support ensuring consistent application of the policies, principles,...

  • IT Risk Assurance Leadership Position

    3 weeks ago

    Sydney, New South Wales, Australia KPMG Full time

    KPMG's IT Auditing team is a dynamic and forward-thinking group of professionals dedicated to evaluating the technology environment of our clients. We are seeking experienced leaders to join our growing team as Associate Directors, playing an active role in shaping KPMG's Technology Risk and Assurance service line.

  • Epmo Project Assurance Analyst

    6 months ago

    Sydney, Australia IT People Australia Pty. Ltd. Full time

    Maintain and refine a scalable internal and external project assurance framework - Collaborate within the EPMO and Divisional PMOs to align to program and project - Ensure appropriate Assurance plans are in place and agreed The purpose of this role is to work with program and project practitioners to provide, or facilitate provision of, analysis, insights...

  • IT Risk and Assurance Leader

    3 weeks ago

    Sydney, New South Wales, Australia KPMG Full time

    About KPMGKPMG is a global professional services firm with deep sector experience. We help our clients across various industries to overcome complex challenges, drive change, and foster growth.We believe that diversity of thought, background, and experience strengthens relationships and delivers meaningful benefits to our people, clients, and...

  • Quality Assurance Associate

    6 months ago

    Sydney, Australia Device Technologies Australia Full time

    **About us** **Since 1992, Device Technologies has been dedicated to improving patients’ lives through leading edge technology and services, **supplying hospitals and healthcare professionals with high-caliber medical solutions from around the world. Over 30 years, Device Technologies has developed a reputation for the quality, dedicated service and...