Quality Associate
il y a 2 semaines
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States.
Our mission is to deliver on the promise of precision medicine through targeted radiation.
At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases.
You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
To contribute to the achievement of the Group's strategic quality goals by supporting the quality management of the commercial scale-up following GMP requirements in Europe.
Coordinate and assist in the active management and implementation of the Telix commercial program/s as directed, including aspects of quality requirements.
Actively participating in and supporting the quality needs of the commercial programs across the organisation's country jurisdictions. Provide support to other TLX programs and other team members as required.
The role is located in Telix Innovations - Herstal, Belgium, with the role reporting to the local Senior Quality Assurance manager.
About You
Education and Experience:
- Bachelor's degree required. Orientation in pharmacy, biochemistry or science filed is highly preferred,
- 23 years of experience in quality position from a regulated industry,
- Knowledge of applicable regulations within EU and the USA,
- Technical understanding of manufacturing, quality and regulatory requirements,
- Previous experience writing and reviewing with understanding SOPs and specifications,
- Languages: English and French fluency.
Key Capabilities:
- Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
- Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
- Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
- Resultsoriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
- Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
- Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
- Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
- Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
- Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
- Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills
Key Accountabilities
- Understand and adhere to GMP Policies.
- Prepare, review and approve documents within Telix Quality Management System (QMS) and eQMS, Master Control.
- Maintain quality requirements, quality system registers and training on Telix QMS.
- Participate in writing, implementing and approving Deviations, Investigations, CAPA Change Control and complaint reports.
- Participate in the management and completion of internal quality audits on all Telix systems within the QMS, prepare reports and recommend solutions and close out activities under the guidance of the Senior Quality Assurance Manager.
- Participate in the management of supplier quality audits, vendor assurance activities and supplier quality agreements.
- Participate in the management of CMOs (vendors involved in manufacture, production and quality control) and other external suppliers (vendors involved in distribution) in compliance with EU GMDP and other global requirements.
- Collaborate with production / manufacturing teams to monitor all work according to requirements under Telix quality system. Review and evaluate all standard operating procedures, batch records and quality control results to ensure compliance with Telix quality and regulatory requirements.
- Participate in batch release activities for Telix in the QMS for commercial and clinical products (as required).
- Provide support to crossfunctional team.
- Identify required system and process gaps within the Telix QMS and facilitate corrective and preventative actions as required
Why work at Telix ?
We are an ASX-listed, dynamic and fast-growing biopharmaceutical company headquartered in Melbourne with offices across Europe, the United States and Australia.
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