URGENT: Qualified Person (QP)

Location: Dublin  |  City of Dublin  |  Ireland
Sector: Life Sciences
Consultant: Matthew Pitcher
Job Reference: HQ00000076QP
Salary: £25900 - £34500
Job Status: Permanent / Full Time

We are currently inviting applications for the following position;

Qualified Person

Purpose

To act as a Qualified Person (QP) named on manufacturing licence under the direction of the Head of Quality (QP),

performing batch manufacturing records review and EU QP release and associated activities with responsibility for Bimeda products in accordance with their Marketing Authorisations ( national or European),

their Manufacturing Authorisations and the principles of GMP in line with Directive 2001/83/C as amended by Directive 2004/27/EC and described in Annex 16 of the EU Guide to GMP.

 

Key Responsibilities

To certify that batches of finished product have been manufactured and checked in accordance with the Marketing Authorisation, the Manufacturing Authorisation,

GMP and legal requirements as set out in Directive 2001/83/C

as amended by Directive 2004/27/EC and described in Annex 16 of the EU Guide to GMP

To ensure that the legal requirements regarding imported products have been met

To investigate any quality related deviations and support execution of corrective and preventative actions

and related documents to ensure compliance is achieved and maintained

To be readily available to staff for discussion and advice and also be present during regulatory inspections, if required
Education & Experience Requirements:

 

Essential:

• Bachelor’s degree in chemistry, biology or a related discipline

• Quality experience in aseptic or sterile processing

• Eligible to practice as a Qualified Person or Responsible Person.

• High level of professional competence

Key Skills, Abilities, and Competencies:

• Organization • Critical thinking/ evaluation of process problems

• Data trending and evaluation

• Ability to multi-task in environment with changing priorities

• Strong work ethic

• Ability to work independently