Senior Gcp Quality Auditor
5 months ago
Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.
The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.
Due to continued business demands, we are now recruiting a Senior GCP Quality Auditor with knowledge in the GCP audit arena. This is an exciting new opportunity to be part of a growing global team that is developing and enhancing Ipsen’s audit strategy. You will join a team that is responsible for the audits across all GxPs, a team that is passionate about Quality.
The role involves conducting and managing audit activities with applicable regulatory requirements and company policies and procedures. You will be required to travel globally to conduct audits and attend relevant meetings as required.
Your role will also include:
- Responsible for independently planning, leading, conducting and reporting of routine and non-routine audits in accordance with the approved schedule and timelines
- Responsible for audit report production and approval of CAPA plans in accordance with internal timelines.
- Ensuring the electronic audit quality systems is updated in accordance with relevant timelines
- Responsible for organising and managing around 70% plus audit travel per year in accordance with relevant company policies
- Conduct peer review of audit reports for both internal and external auditors
- Collaborate with the Head of GQA and the audit team to enhance the audit quality management system by actively participating in process improvements including QMS documentation updates
- Maintain current awareness of the regulatory and pharmaceutical industry environment and, as a result, can influence internal Business Partners and stakeholders on best quality & compliance
- Acts as Subject Matter Expert / Point of Contact to provide expertise and knowledge to Business Partners on quality and compliance processes/procedures.
To be considered for this role, you will have a bachelor’s degree in a scientific or health-related field. Lead auditor qualification/certification. Minimum 5 years’ experience in conducting GCP audits, regulatory inspections related to GCP would be an advantage. Ability to work independently without supervision is essential.
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