Qualified Person (QP)

Job Title:Qualified Person (QP)

Type:Permanent, Full-time

Location:Hatfield, Hertfordshire, UK (onsite)

Summary:

As the Qualified Person (QP), you will be responsible for supporting the Associate Director Quality Operations in the implementation and maintenance of the manufacturing sites Quality Assurance activities relating to product support used for the manufacture, packaging, testing, storage and distribution of marketed products. Ensuring that operations are compliant with current GMP and Corporate expectations. Enhancing quality policies, systems and procedures as appropriate. Carry out legal duties of a Qualified Person (QP) as specified under EC directive 2001/83/EC as amended and 2001/20/EC.

Responsibilities:

• Extensive knowledge and experience of Quality Assurance, Quality Systems, GMP guidelines and an understanding of the manufacture and packaging of pharmaceutical products
• Ability to establish and maintain effective working relationships and communication links within the manufacturing site, affiliated organisations and other customers
• Good technical and scientific judgement
• Ability to interpret complex data and present key findings
• Computer literate e.g. Word, Excel and PowerPoint
• Able to act as a mentor in support of Quality staff development
• Ability to conduct audits internal and externally
• Proven Analytical and problem-solving ability

Qualifications:

• Trained as Qualified Person (QP) with strong understanding of EU&UK legislation
• Oral solid dose or sterile products experience