QP/Qualified Person

Desired Skills: qualified person,qp,qp qualified

PE Global are currently recruiting for a Qualified Person/QP for our client site in Sligo on a 12 month initial contract:

Fully onsite, Biologics site

Responsibilities

Comply with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release; Article 47 of Directive 2001/83/EC.
Qualified Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the Product Specification File (PSF)/Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP) for products manufactured
To ensure that products manufactured are manufactured in accordance with the relevant GMPs. The Quality Assurance Specialist / Qualified Person (QP) is responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.
To disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch

Requirements

Third level qualification in a science discipline with 5 years’ experience in the pharmaceutical industry.
MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
5 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
2 Years’ experience gained within an aseptic processing environment, ideally gained within a quality function

Cognitive Skills

High level of expertise is required to assess day to day quality issues.
Must become familiar quickly with products and processes in order to assess quality issues.
Must have good interpersonal skills

Ownership/Accountability

Every employee has a personal responsibility to commit to the Vision, to engage and align with the Strategic Imperatives, and to consistently execute in accordance with the Operational Pillars and Ways of Work.

Influence/Leadership

May be required to support Cross functional teams and cost improvement projects.
Provides guidance to suppliers as required to maintain a compliant efficient relationship.
Provide technical leadership to functional areas and collaborates with key stakeholders

Decision Making/Impact

Decision making within confines of quality systems in relation to applicable regulatory and international standards.
Expected to handle all day to day quality issues/queries from the operations function, however, if a major problem occurs they will confer with relevant personnel or Team Leader.
Decision making within confines of agreed responsibility with Team Leader.

Supervision Received

Individual is given authority to carry out their duties without close supervision.
Reports to Quality Operations Manager.

Supervision Provided

EHS Responsibilities

Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities;
Continually be conscious of your own safety and that of others, always complying with safety notices and barriers;
Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
Attend all required EHS training and medical surveillance programs.
Wear PPE as required.

Interested candidates should submit an updated CV, marked for the attention of Audrey

audrey.mccarthy@peglobal.net or 00353 21 4297900