Qualified Person & Responsible Person


Contract Qualified Person: Registered with the Irish Medicines Board to release medicinal product from pharmaceutical companies for numerous markets e.g. European, Australian, Japan and American.

Contract Responsible Person: Registered with the Irish Medicines Board to maintain wholesale licence to store and distribute medicinal product.

QP/RP will review documentation and system to ensure compliance with requirements.

 

Qualified Person

FQS QP & RP

  • Contract Qualified Person: Registered with the Irish Medicines Board to release medicinal product from pharmaceutical companies for numerous markets e.g. European, Australian, Japan and American.  Review documentation and system to ensure compliance with requirements.
  • Implement and maintain Manufacturing Licence, quality system and register with Irish Medicines Board to release pharmaceutical product.
  • Experience as a Qualified Person with different forms (e.g. solid dose, liquids, semi solids), contract manufacturing and packaging, controlled drugs, developmental and clinical trials.
  • Comply with Manufacturing licence, product authorisation and relevant legislation and guidelines ensuring all the Principal Duties and Responsibilities are met.
  • Using the knowledge of regulations, product stability and product/licence requirements, FQS ensure products are released in compliance to the systems in place.  FQS supports continuous improvements and reduces release times and deviations and increases right first time.
  • FQS can provide contract qualified person on a short term basis e.g. to cover holidays, maternity/parental leaves or long term contracts bringing experience and up-skilling staff in issue resolution.

 

Responsible Person

FQS qualified person responsible person

  • Contract Responsible Person: Registered with the Irish Medicines Board to maintain wholesale licence to store and distribute medicinal product.  Review documentation and system to ensure compliance with EU requirements.
  • Implement and maintain Wholesale Licence and register with Irish Medicines Board to store and distribute pharmaceutical product.
  • Experience with a vast range of regulatory authorities.
  • Ensure compliance with current Good Distribution Practice (cGDP) Requirements, including, but not limited to documentation control and all stages of storage and distribution.
  • Comply with Wholesale guide and ensure all the Principal Duties and Responsibilities are met.
  • FQS can provide contract responsible person on a short term basis e.g. to cover holidays, maternity/parental leaves i.e. Deputy responsible person or long term contracts bringing experience and up-skilling staff in issue resolution.

 

Contact FQS for more on contract Qualified Person / Responsible Person (QP/RP)