Quality Assurance Manager

• Manage site Quality System for compliance with company policies and procedures.
• Ensure Recall procedure compliance with regulatory and company requirements.
• Oversee Quality Documentation System (SOPs, forms, policies) for regulatory compliance.
• Initiate and manage change requests through Change Control process.
• Participate in reviewing quality system documents undergoing change.
• Manage Deviation/CAPA/LIS system, ensuring thorough investigations and records.
• Investigate and document customer complaints promptly and comprehensively.
• Apply and maintain effective Risk Management System at the site..
• Monitor and approve Calibration and Certification activities.
• Coordinate external audits (e.g., regulatory bodies, customer) professionally.
• Assist in Validation activities as per Validation Master Plan.
• Approve validation protocols as required.
• Manage external GMP/service contracts with providers.
• Serve as primary license holder for facility.
• Communicate transparently with Senior Management and regulatory bodies.

Skills:

• Degree qualified with appropriate science-based degree.
• At least 3 years relevant industry experience.

Apply directly now, or send your updated CV to Ben Byrne at bbyrne@i-pharmconsulting.com OR (02) 8310 5849.