Audit Readiness Coordinator

Summary: The Audit Readiness Coordinator role in Copenhagen involves overseeing and planning audit tasks within a global pharmaceutical manufacturing environment. This position supports a large-scale CAPEX investment program, ensuring compliance and readiness for audits and inspections. The role requires collaboration with various stakeholders and alignment with quality assurance standards. It presents an opportunity to contribute significantly to the biopharmaceutical industry.

Key Responsibilities:

• Provide oversight and plan for all relevant audit tasks and topics.
• Provide overview of supplier and owners of each audit tasks and topics.
• Prepare templates used to prepare and present at audit.
• Coordinate with stakeholders for audit/inspection that deadlines and tasks are met.
• Ensuring alignment with the PQS department on quality and form.
• Coordinate with PQS department, regarding resources for audit and inspection and regarding communication.
• Track progress of audit readiness and report to operational readiness.
• Assist QA Project Director and Audit Readiness Lead on monitoring compliance in projects.

Key Skills:

• Extensive Project QA experience in a pharmaceutical manufacture/biopharmaceutical environment.
• Knowledge of and experience running audits and inspections, setup and tasks.
• Knowledge of EU GMP Vol 4 and how this applies to projects.
• Knowledge of how to report to management at various levels/stakeholders.

Salary (Rate): undetermined

City: undetermined

Country: Denmark

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other