Qualified Person - QP - EU Consultancy - Dublin


Location: Ireland

EUR 90,000 - 110,000

Job Type: Perm

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1901-12517

Consultant: Karen McHugh






Are you a Qualified Person with 5+ years pharma / biotech industry experience

If you have the relevant experience for this role, please contact Karen on +353 1 7978720 or send your CV to karen@jobcontax.com for review?



Qualified Person - QP - EU Consultancy - Dublin


Employer

Our client are a specialist life science consultancy.

They offer bespoke services in regulatory affairs, product development, quality assurance, drug safety, medical information, copy approval, project management, training and market access.


Job Description

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

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


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)

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


Package

Hourly contract rate €90k - €110k

Excellent Benefits


Contact

Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or call +353-1-7978720

TAGLab


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