Job Type: Contract
Job ID: JO-1812-12176
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 firstname.lastname@example.org for review?
Qualified Person - QP - Contract - Dublin
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.
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
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
Hourly contract rate €80 - €100 per hour
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact Karen by e-mail email@example.com or call +353-1-7978720
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