Total 6 research associate job vacancies in Quality Assurance / Control category in nsw sydney northern sydney central coast

29th October,
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 innovative solutions that enhance the well-being of our customers. Arrotex Pharmaceuticals is the largest and most diverse pharmaceutical company in Australia. Our vision is to be the most trusted provider of affordable and quality healthcare products and services to deliver a better quality of life for Australians. Our values of Pioneering, Accountability, Collaboration, and Tenacity are the PACT our team members make to be our best every day and work together to deliver this vision and create a great place to work.     About the role:      The Quality Assurance Team Leader leads a team of Quality Assurance Associates to perform product verification activities and to release products for distribution. The Quality Assurance Team Leader ensures
... Click here to view more detail / apply for Senior Quality Assurance Associate/ Team Leader

Purpose of Role

• Develop and maintain the highest standards of quality and compliance to support Sobi’s practices in Australia.
• Implement systems and processes to ensure that Sobi products in Australia consistently meet or exceed established quality standards.
• Lead activities related to Good Manufacturing Practices (GMP), Quality Management Systems (QMS), and adherence to regulatory requirements.
• Ensure compliance with Industry Code of Conduct and company guidelines.

Job Description:

• Oversee, manage and update the Sobi QMS in Australia, including training rollout, annual reviews and ad hoc updates as required, and on a timely basis.
• Collaborate closely with Supply Chain to ensure the required quality standards are met; Review records and change requests on completeness, consistency, relevance and clarity;
• Review and approve GxP documents, ensuring all processes follow GxP;
• Prepare batch release documentation;
• Approve QA-controlled documentation (such as SOPs, batch records, working instructions);
• Conduct regular self-inspection activities to ensure audit readiness
• Support the development of Corrective and Preventative Actions (CAPAs) and continuous improvement activities;
• The role is based in Sydney – office-hybrid, reporting to the Finance and Operation Manager.

Key Responsibilities:

• Provide leadership in all matters relevant to the QMS (continuous improvement, training, etc.);
• Develop and manage company policies and Standard Operating Procedures (SOP) required by the QMS;
• QTC - Facilitate and assign related training to the affiliate employees;
• Sign relevant document after review of importation and repacking documents;
• Conduct root cause analyses, identify CAPAs, and determine product disposition to maintain the quality standards;
• Log non-conformance, change control and CAPAs into the QMS system;
• Assign to relevant stakeholder, follow up actions and closure;
• Support internal/external audits;
• Lead recall actions;
• Other projects, tasks and responsibilities as assigned by management;
• Behave ethically, responsibly, and professionally in accordance with Sobi’s values, internal policies and Australian Medicines Code of Conduct.

Full-time permanent position based in Sydney
Be at the forefront of medicinal cannabis regulation changes and evolution!
Get involved in an industry that is undergoing rapid growth and market potential
Our client, a medicinal cannabis wholesaler is looking for a Compliance / Regulatory Affairs Associate to assist in reviewing the regulatory compliance of the business activities.
  
You will be supporting the preparation and submission of license applications, permits and registrations needed for cannabis product distribution. You will also be maintaining the accuracy of regulatory documentation and records.
  
Your other responsibilities will also include, but not be limited to:


Coordinating with regulatory authorities / external consultants to facilitate the licensing processes
Reviewing product labels, packaging and promotional materials to ensure regulatory compliance
Assisting in product complaints and other ad hoc compliance activities
This is a great opportunity for a regulatory ... Click here to view more detail / apply for Compliance / Regulatory Affairs Associate

29th May, 2024
    Arrotex Pharmaceuticals is seeking a highly motivated and detail-oriented Senior Quality Assurance Associate to join our dynamic Scientific Affairs team.   Reporting to the Technical Manager, the Senior Quality Assurance Associate will work collaboratively with internal and external stakeholders to ensure that our pharmaceutical and healthcare products meet the highest standards of quality and compliance. This role will focus on quality risk management for our pharmaceutical product quality complaints process to ensure appropriate triage, prioritisation and action for product quality issues          Benefits and Culture:      

Competitive remuneration package
Annual Bonus Structure
Fantastic team culture
Purchased leave scheme.
Paid parental leave.
Benefits/discount platform
Novated car leasing
Opportunity to advance your career with a growing team and company.
  
  
Key Responsibilities:

... Click here to view more detail / apply for Senior Quality Assurance Associate

Our client based in Victoria is looking for a Senior Associate to work in the sterility assurance team.
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 practiceTraining
•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

At Xe, we live currencies. We provide a comprehensive range of currency services and products, including our Currency Converter, Market Analysis, Currency Data API and quick, easy, secure Money Transfers for individuals and businesses. We leverage technology to deliver these services through our website, mobile app and by phone. Last year, we helped over 300 million people access information about the currencies that matter to them and over 225,000 people used us to send money overseas.

We are proud to be part of Euronet Worldwide (Nasdaq: EEFT), a global leader in processing secure electronic financial transactions. Under their Money Transfer division, Xe and Ria Money Transfer have been brought together to help establish the third largest money transfer business in the world.

Reporting into the Compliance Operations Manager you will understand the value the compliance operations functions have in delivering key business objectives and have the foresight to spot opportunities to innovate and develop new ways of operating.

Our Principles

AMBITION: We dream big, try things out and always ask “why not?” and “what if?” We’re ambitious in our thinking and our delivery

RESPONSIBILITY: We get involved, bring our perspective and are always open to new ideas. We take personal responsibility

COMMUNITY: We value a sense of belonging, trusting each other and encouraging authenticity. We contribute to our community

WHAT YOU’LL DO

Great Attention to Detail: Conduct Customer Due Diligence and Enhanced Due Diligence for new corporate and consumer relationships

Strong Investigative Skills: Complete ongoing monitoring of customer relationships on the back of trigger events or through their regular review cycle. Investigate transaction monitoring alerts and evaluate whether they are unusual or suspicious

PEP & Sanctions Screening: Review PEP and Sanction screening referrals for clients and beneficiaries at registration and transactional level in line with Xe’s policy

Analytical & Trends: Analyse transaction data and fraud metrics to determine trends and indicators which may assist in detecting and preventing online fraud

Operational Compliance:

• Remain up to date on Xe’s core business activities and assist in the analysis of proposed business initiatives from a compliance operations perspective
• Provide day to day compliance operations assistance and support to wider teams within Xe
• Act as a contact and reference point for Compliance Operations Analysts e.g. handling escalated queries
• Conduct training for new starters and analysts on an ongoing basis
• Provide walkthroughs of systems to internal and external stakeholders

Quality Control: Conduct Quality Control checks on Compliance Operations Analysts to ensure Xe maintains consistency and accuracy whilst striving for continuous improvement of the compliance operations function

Situational Adaptability: Maintain high levels of performance at all times including situations with challenging timeframes and complex situations and scenarios

Team Culture: Foster a positive, inclusive, collaborative team culture by maintaining open professional communications and being a team player

Process Improvement & Efficiencies: Strive towards continuous improvement of the compliance operations function

• Passionate about Compliance: At least 3 years’ experience gained working within a similar role within the FX/Payments industry or within a similar regulated organisation
• Effective Communicator: Excellent communication skills, ability to build relationships and communicate effectively
• Prioritisation & Organisation: Strong organisational skills to enable identification of required tasks and deadlines and planning and prioritisation of these tasks in an appropriate manner
• Customer focused: Client-focused approach with a passion for delivering excellence
• Adaptable: Ability to work as part of a global team, sharing best practice and working collaboratively to raise the bar across the organisation
• Fluency in English with confident verbal and written communication skills
• Ability to work flexible hours and possibility of evening and weekend work

Desirable:

• Expertise in using tools such as Compliance Catalyst, Actimize and Accertify
• ICA Diploma or Advanced Certificate in AML/Financial Crime, ACAMs

• Competitive market-based salary
• Annual Discretionary Bonus
• Superannuation
• Healthcare
• 20 days annual leave increasing with each year of service (capped at 25 days)
• Paid day off for your Birthday
• Discounted Euronet Employee Share Purchase Plan (ESPP)
• Plumm Mental Health and Wellbeing