AddressBluefin Resources is a proud partner of a disruptor in the healthcare industry. They are seeking an experienced Quality Assurance Specialist to assist us in building out a robust Quality Assurance function and charged with coordinating and implementing key projects in their QA Action Plan. The ideal candidate is an exceptionally organized, methodical professional who has the experience necessary to take this function to a level commensurate with an industry leading organisation.
Key Responsibilities:
- Spearhead the development of our client's QMS/eQMS platform, paving the way for streamlined processes and enhanced efficiency.
- Take charge of coordinating risk registers for our client's QA functions, collaborating closely with their Compliance Manager to develop and execute risk treatment plans.
- Partner with internal stakeholders to establish a supplier pre-qualification process, including rigorous technical validation of third-party manufacturers and laboratories.
- Lead the charge on developing and implementing a comprehensive supplier assurance program, ensuring the highest quality standards across the supply chain.
- With your keen eye for detail, proactively identify and manage quality and compliance risks, turning challenges into opportunities for growth.
To be successful for this role, you will have:
- Bachelor's degree in science, pharmacy or related field.
- 5 years Quality Assurance work within a GMP regulated environment.
- Deep knowledge of Quality Assurance terminology, methods, and tools.
- Superb computer skills, including database management.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong stakeholder management capabilities, along with the resilience to thrive in fast-paced environments.
- Current satisfactory national police check.
- Ability to travel domestically for work-related purposes up to once per month.
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