Audit Readiness Coordinator
- Denmark
- Contract
- Compliance / Quality Assurance
Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Audit Readiness Coordinator to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry.
Responsibilities include:
- 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.
- 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.
#LI-ML1
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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Megan
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