Head of Quality Assurance
1 day ago
We are seeking a seasoned Head of Quality to spearhead our quality and compliance agenda within our GMP facility.
Key Responsibilities:- Strategic Leadership: Set the strategic direction for quality and compliance, overseeing all related functions to align with clinical trial requirements and regulatory standards.
- GMP Compliance: Guide the business in maintaining a GMP-compliant facility licensed through TGA, maintaining the electronic Quality Management System (e QMS), approving documentation, and training staff on GMP practices specific to clinical trial production.
- Quality Assurance: Establish and maintain robust quality assurance protocols that encompass the entire lifecycle of clinical trial products—from development to production, ensuring that all processes meet regulatory and company standards.
- Risk Management: Strengthen internal capabilities to achieve project outcomes while effectively managing operational quality controls and risks associated with clinical trial products.
- QC Oversight: Oversee the Quality Control (QC) function, ensuring timely completion of tasks, including effective investigations of out-of-specification (OOS) results and implementing corrective and preventive actions as necessary.
- Cross-Functional Collaboration: Collaborate with clinical, development, and production teams to ensure seamless integration of quality assurance practices into production processes, emphasizing adherence to protocols and timelines.
- Regulatory Expertise: Act as a key point of contact for regulatory inspections and audits, demonstrating a deep understanding of quality assurance principles and compliance regulations related to clinical trials.
- Authorised Person Responsibilities: Serve as the Authorised Person, fulfilling all GMP responsibilities, ensuring that all standards are met before the release of clinical trial products.
Requirements:
- Detail-Oriented: A meticulous approach to quality assurance, with a keen eye for details that can impact product safety and efficacy.
- Analytical Thinker: Strong analytical and problem-solving skills to navigate complex quality issues and implement effective solutions in a fast-paced environment.
- Effective Communicator: Excellent communication skills to convey quality standards and protocols to all levels of the organization, fostering a culture of quality and compliance.
- Leadership Skills: Proven leadership capabilities to inspire and guide teams in upholding the highest standards of quality in clinical trial product production.
If you are a proactive leader with a passion for quality assurance in the pharmaceutical industry, particularly in clinical trial products, we invite you to apply and help us maintain the highest standards of quality and compliance at Abinitio Pharma.
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