Qualified Person

About PSC Biotech

• Own, review and approve SOP s and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.
  
• Perform review and approval of validation documentation.
  
• Lead and participate in internal and external audits as needed.
  
• Maintain a close contact and familiarity with **** Quality systems and programs utilized at other *** sites.
  
• Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regard to compliance with quality policies, standards and procedures.
  
• Evaluates and assess change control records, nonconformances and CAPAs.
  
• Participate in global Quality initiatives as a site subject matter expert.
  
• Participate or lead projects and improvement efforts including product launches.
  
• Supports the evaluation of quality and distribution complaints.
  
• Supports regulatory inspections or various questions from regulatory bodies.
  
• Perform activities as required per **** procedures as QA staff, and in particular where the role of QP is specified in the procedures.
  

• In the case of medicinal product manufactured within EU member states, ensure that each batch of medicinal product has been manufactured and checked in compliance with the laws in force in that member state and in accordance with the requirements of the marketing authorisation.
  
• In the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the Community, that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorization.
  
• In the case of medicinal products intended to be placed on the market in the European Union, ensure that safety features have been affixed on the packaging
  
• Certify in a register or equivalent document, that each production batch has been manufactured and checked in compliance with laws in force in Ireland, is in accordance with the requirements of the marketing authorization and with EU Good Manufacturing Practice (GMP).
  
• Ensure batches of medicinal products are distributed as per the Manufacturing Importation Authorisation and EU Good distribution Practice (GDP) as per Directive 2001/83/EC and guidance 2013/C 343/01.
  

• In the case of investigational medicinal products manufactured in the Member State concerned, that each batch of medicinal products has been manufactured and checked in compliance with the requirements of Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (2), the product specification file and the information notified pursuant to Article 9(2) of Directive 2001/20/EC.
  
• In the case of investigational medicinal products manufactured in a third country, that each production batch has been manufactured and checked in accordance with standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/356/EEC, in accordance with the product specification file, and that each production batch has been checked in accordance with the information notified pursuant to Article 9(2) of Directive 2001/20/EC.
  
• In the case of an investigational medicinal product which is a comparator product from a third country, and which has a marketing authorization, where the documentation certifying that each production batch has been manufactured in conditions at least equivalent to the standards of good manufacturing practice referred to above cannot be obtained, that each production batch has undergone all relevant analyses, tests or checks necessary to confirm its quality in accordance with the information notified pursuant to Article 9(2) of Directive 2001/20/EC.
  
• Certify in a register that each production batch satisfies above mentioned provisions.
  

Requirements