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Job Ref.: 1667

Job Title: Responsible Person (RP) – Pharmaceutical Consultancy – Dublin based – September 2018 – Immediate vacancy

Posted Date: 25/09/2018

Sector: Responsible Person (RP)

Location: Ireland, Dublin

Job Type: Permanent full-time

Job description:

Responsible Person (RP) – 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 Responsible Person (RP) to work out of their new Dublin offices. The position is a full-time permanent role.

Purpose of Job

• To maintain the quality system and ensure compliance in terms of GMP, GDP

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

• To host regulatory agency inspections and customer audits

• To undertake audits as required

• Provide training in 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 Responsible Person in accordance with the HPRA’s educational requirements, experience, training and licensing (compliance with the requirements of Directive 2013/C 343/01)

• Compliance with the requirements of the Cogent Gold Standard

• The RP shall reside and operate in the Republic of Ireland

• The RP should have a complete programme of Continuous Professional Development (CPD)

Attributes

• The RP should have skills to maintain 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 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 the Quality Management System of the company in accordance with the requirements of ICH Q 10

To operate in accordance with the company’s Standard Operating Procedures

To support agency inspections

To undertake or arrange for regular auditing as required of:

• Drug product manufacturers and suppliers

• Drug product distribution sites

• Drug product distribution channels and customers

• The company’s internal quality systems

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

NB - Your application and details are treated in the strictest confidence by us at all times.  We comply fully with GDPR guidelines (May 2018). Please see our privacy policy on www.pharmasolutions.ie

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

 

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