LSC has an exciting opportunity for an Audit Readiness Coordinator to join a pharmaceutical company in Denmark. This will be a dynamic environment that is constantly innovating, relies on cutting-edge technology to deliver life-saving medicines. You will be working in a site that supplies active ingredients through complex chemical synthesis and biotechnology manufacturing processes for a range of therapeutics. This is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Manage and coordinate between the project organizations and Site to prepare for Mock audit and authority inspection of the facilities.
- Provide oversight and plan for all relevant audit tasks and topics.
- Provide overview of supplier and owners of each audit tasks and topics, such as equipment or validation process.
- Prepare templates used to prepare audit topics/equipment to be presented at audit.
- Coordinate with stakeholders for audit/inspection that deadlines and tasks are met
- Coordinate with audit team, regarding resources for audit and inspection and regarding communication.
- Track progress of audit readiness and report.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Knowledge of and experience running audits and inspections, setup and tasks.
- Knowledge of qualification and validation
- Knowledge of EU GMP Vol 4 and how this applies to projects
- Knowledge of how to report to management at various levels
- Self-driven and structured
- Good in creating relations and maintain a positive connection
- Ability to stay firm on decisions, and find possible alternative solution paths
Call LSC on Gráinne Hodnett at (021) 477 7329 to discuss in detail or apply directly via this advert.
