Consultant QP

Team Horizon currently has an exciting opening for a Consultant QP to work at our client’s facility in Sligo 1 – 2 days per week. This is an exciting opportunity to join a fast paced start up environment, where you will be responsible for the Batch Certification and Release of pharmaceutical products for human and veterinary use which have been packaged at our client’s facility in accordance with requirements of Article 13.3 of Directive 2001/20/EC, the requirements of EU GMP Volume 4, Part 1 and Annex 13.
 
Why you should apply:

• This is an opportunity to work with an established Irish owned Early Phase supply partner, who value patient safety and Quality above all else.

 
What you will bedoing:

• Ensure that all Quality Technical Agreements (QTA’s) are approved and in place prior to the start-up of packing operations for pharmaceutical products.


• Assist in the development of the quality system on site


• May provide annual and on-going refresher GMP training for all staff.


• Review the functioning to the quality system through regular participation in internal audits and assessment of the findings.


• Liaise with the Irish HPRA as required in the acquisition of the Manufacturing and Importation Authorizations (MIAs).


• Assist with the investigation of customer complaints and process deviations.


• Provide Management team with expertise on issues of quality as they arise.


• Ensure that batch dispositions and certification decisions are made independently of the Quality and Production Managers


• Ensure that that the Quality Management System is designed and operated in a manner which complies with the requirements of EU GMP Volume 4. Part 1 and relevant Annexes


• To ensure that every batch of pharmaceutical product packed is in compliance with the laws in force in the state in respect of such product, the provisions of the relevant MIA, the provisions of the relevant QTA or other quality standards which relate to said product.


• Ensure that the principles of Good Manufacturing Practice (GMP) are understood and followed at all times

 
What you need to apply:

• MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC