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Job Ref.: 1668

Job Title: Qualified Person (QP) – Pharmaceutical Consultancy – Dublin based – September 2018 – Immediate vacancy

Sector: Qualified Person (QP)

Location: Ireland, Dublin

Job Type: Permanent full-time

Job description:

Qualified Person (QP) – Pharmaceutical Consultancy – Dublin based – September 2018 – Immediate vacancy

Our client is a well-established pharmaceutical consultancy company based in the UK.  The company currently operates from two sites in the UK. The company offers a wide range of services including all aspects of regulatory affairs, quality, development, pharmacovigilance, medical information and market access services among other allied offerings.

Following the UK’s decision to exit the European Union, our client has now established an Irish registered sister company. Although, this company was only established at the beginning of 2018, it already holds some approved Irish Marketing Authorisations for medicinal products.

They are now looking to recruit a Qualified Person (QP) to work out of their new Dublin offices. The position is a full-time permanent role.

Purpose of Job

  • To manage the quality system and ensure compliance in terms of GMP, GDP, GVP (GVP in conjunction with QPPV) and GCP

  • To fulfil the Company’s requirements with respect to Qualified Person services

  • To fulfil the Company’s requirements with respect to Responsible Person services

  • To host regulatory agency inspections and customer audits

  • To provide quality support to the pharmacovigilance function

  • To undertake audits as required

  • Provide training in GMP/GDP as required

Qualifications and Role Requirements

  • Life science degree, preferably within the sphere of pharmacy, chemistry, pharmaceutical chemistry or biology
  • A minimum of 5 years pharmaceutical industry experience
  • Attainment of the status of Qualified Person in accordance with the HPRA’s educational requirements, experience, training and licensing (compliance with the requirements of Directive 2003/94/EC)
  • The QP shall reside and operate in the EEA
  • The QP should have a complete programme of Continuous Professional Development (CPD)

Attributes

  • The QP should have skills for the management of the quality functions of the Company
  • Ability to work cross functionally within the Company and practically apply GMP / GDP and associated legislation

Main Duties and Responsibilities

To perform the Qualified Person duties in accordance with Article 51 of Directive 2001/83/EC as amended.

These duties shall include:

  • ensuring that Good Manufacturing Practice (GMP) has been adhered to
  • ensuring that the requirements of the product registration and of the manufacturer’s licence have been met
  • ensuring that manufacturing and testing processes have been validated
  • ensuring that all necessary quality control checks and tests have been conducted
  • ensuring that the legal requirements for nationally manufactured and imported products have been met. For products imported from outside the European Union (EU) or European Economic Area (EEA) the QP should ensure testing within the EU/EEA to requirements of the product registration and any other tests to assure quality of the products, unless a Mutual Recognition Agreement exists between the EU and the third country concerned
  • Batch release and certification

To perform the Responsible Person duties in accordance with Articles 76 and 85 of Directive 2001/83/EC as amended.

These duties shall include:

  • ensuring that the provisions of the licence are observed
  • ensuring that the operations do not compromise the quality of medicines
  • ensuring that an adequate quality system is established and maintained
  • to oversee audit of the quality system and to carry out independent audits
  • ensuring that adequate records are maintained
  • ensuring that all personnel are trained
  • ensuring full and prompt cooperation with all parties in the event of recalls.

Maintain and manage the Quality Management System of the company in accordance with the requirements of ICH Q 10 and PVG Module 1 (GVP in conjunction with QPPV

To provide oversight control of the company’s Standard Operating Procedures

To manage agency inspections of the company

To undertake or arrange for regular auditing as required of:

  • Drug substance manufacturers
  • Drug product manufacturers
  • Drug product testing sites
  • The company’s internal quality systems
  • Clinical testing facilities

An excellent salary plus strong benefits package will be offered to the successful candidate.

For further information, please call Paul Flanagan at +353 1 805 5522 or email your c/v in the strictest confidence to paul@pharmasolutions.ie

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Also, please see the full range of our job listings on the Pharma Solutions website which is updated daily

 

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