Combine site inspection management and internal audit activities in a developing corporate network setting requiring a limited amount of travel.
Administrate and coordinate the inspection readiness program for regulatory inspections aligned with company objectives and oversee the execution of inspection activities and timely management of regulatory stream activities through to commitment implementation.
Manage external (regulatory and corporate) audits and assure Company practices meet TGA, PIC/S GMP, FDA, MHRA, EMA, Health Canada, cGMP and other regulations.
As member of a developing corporate internal auditor group, perform internal audits at the site as participant and internal audits at other IMOQ sites as Lead auditor.
Partner with key stakeholders to provide direction and guidance on GMP Compliance matters
Administrate the Site Quality Review Team (SQRT) and Ad-Hoc SQRT
Drive a proactive quality culture across the Company to deliver products Right First Time (RFT).
Qualifications
Bachelor’s Degree in Scientific or related discipline with 5 years experience or 3 of 5 years in a Quality function.
Demonstrated experience working in a cGMP (current Good Manufacturing Practices) environment with strong understanding of Quality Systems functions
Experience in preparing and participating in audits and inspections
Self-motivated with a proven ability to deliver results in a team environment
Excellent technical writing, communication, and presentation skills
Proficiency in Microsoft Office and Date Analytic Tools
