Description
Responsibilities:- To liaise with customers with regard to their requirements, determining their needs and timelines and to manage client projects including the preparation of project proposals and the implementation of Project Plans including timelines and costings.
- International auditing procedures and in line with all Pharmaceutical Regulatory requirements and Standards, to highlight deficiencies to the customers and to support (as required) in the remedy of those deficiencies.
- To advise and support companies in the establishment and improvement of their Quality Systems.
- To follow-up with existing customers to ensure satisfaction with service.
Knowledge
In-depth understanding of regulatory requirements applicable to the Pharmaceutical Industry, and knowledge of the sources of regulatory information medical devices and cosmetics industries also considered. In-depth understanding of the purpose, objectives and scope of Quality Systems.
Qualifications / Experience
- 3rd Level Qualification in Science or Quality Management
- In excess of 10 years' experience in GMP in sterile and biotech drug products.
- 10+ yrs experience in Quality Assurance or Quality Compliance role.
- High level Computer Literacy and competency - Microsoft Office, Microsoft Project.
- Ideally, a QP Vendor Auditing Experience Knowledge, Skills & Behaviours