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Quality Assurance Team Leader
2 months ago
About Programmed
Programmed is seeking a skilled Quality Assurance Supervisor to enhance our Australian Operations Leadership Team. This pivotal role is essential for maintaining the quality of pharmaceutical products and ensuring compliance with global Quality Management Systems (QMS). You will lead a committed QA team, oversee the product release process, and ensure adherence to all applicable standards and regulations.
Key Responsibilities:
- Review and validate all documentation related to product disposition.
- Ensure that serum (API raw material) meets all relevant specifications and standards.
- Assess Non-Conformances, Out of Specification Results, QC testing, and Environmental Monitoring data.
- Guarantee compliance with the organization's QMS and Quality Policy.
- Issue manufacturing records and coordinate CAPA review board and CCRB meetings.
- Represent QA in discussions regarding Quality Events (QE), CAPA incidents, and Quality Risk Assessments.
- Conduct internal and external GLP/GMP audits to ensure compliance with TGA, FDA, and other regulatory authorities.
- Review and audit Sheep Health Reports for accuracy and adherence to SOPs.
- Continuously analyze QMS trends to implement Continuous Improvement strategies.
- Assist the Quality Manager in ensuring compliance with GMP as recommended by TGA, MHRA, and FDA.
- Support the development of a competency-based training program for the QA department.
- Maintain, review, and approve GMP documentation, ensuring alignment with company standards.
Qualifications and Skills:
- Degree in Chemistry, Biochemistry, Microbiology, Immunology, Pharmacy, Life Science, or a related field (highly desirable).
- At least 5 years of experience in a senior Quality role within the Pharmaceutical/Biotechnology sector.
- Thorough understanding of cGMP and the ability to conduct self-audits.
- Proficient in IT, especially in Excel and Word.
- Excellent communication skills, capable of engaging with stakeholders at all levels.
- Highly organized, detail-oriented, and able to prioritize tasks in a fast-paced environment.
- Creative problem-solver with a flexible, proactive approach.
- Collaborative team player with the initiative to drive quality enhancements.
Work Environment
At Programmed, we provide a supportive environment and infrastructure that allows you to excel while offering the flexibility to make a significant impact within the organization. You will receive a competitive salary based on your experience and ongoing commitment to professional development and advancement.
Commitment to Diversity
Programmed is dedicated to creating a safe and inclusive workplace that values and respects diverse styles, backgrounds, experiences, and perspectives. We encourage applications from women, individuals of Aboriginal and Torres Strait Islander descent, and people from diverse backgrounds.
