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Qualified Person

Qualified Person



Qualified Person (QP)
 
 
Could this QP role be your next dream job?  Are you an experienced QP within the Pharmaceutical Industry looking for your next challenge?
 
If you are interested in a fantastic opportunity working at an innovative company then look no further, this is the job for you!
 
This is a permanent full-time job based in Dundalk.
 
 
What will you do in this job?
 
Ensuring the company maintains their eligibility to remain on the QP register having satisfied the requirements laid down in Article 51 of Directive 2001/83/EC or Article 55 of Directive 2001/82/EC
 
Ensuring their experience in the process or dosage form is current and satisfies the legal requirements and where necessary seek training or mentoring from subject matter experts
 
Ensuring their knowledge is up to date
 
Working within the professional code of conduct as well as the Code of Practice produced jointly by the three professional bodies
 
Advising the company on aspects of assembly of licensed products, the Medicines Act and regulations, the principles of GMP, storage and distribution of finished goods
 
Routinely monitoring the company's operations to ensure compliance with their manufacturers licence and Good Manufacturing Practice, bringing any non-compliance to the attention of senior management
 
Ensuring that each batch of medicinal product has been manufactured and checked in compliance with regulations
 
Participating n the company internal audit programme and training programme as required
 
Liaising with Regulatory Agencies as required
 
Acting as a sponsor to Trainee QP's as required
 
Support the RP in their duties
 
 
What do you need to be successful in this job?
  • Bachelor's Degree in a related discipline
  • Qualified QP with 3-5 years + experience in a Pharma/Biopharma environment
 
 
What's in it for you?
  • A competitive salary with incentives/bonus.
 
And… much more!
 
 
The Next Step for you:
 
Interested in this role? Please send your CV to GILLIAN DUNPHY at Next Generation Recruitment by clicking on the Apply button!
 
Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there.
 
Next Generation specialise in Life Science, Engineering, Supply Chain & Operations, Data Science, Digital Marketing, and IT.
 
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