Quality Specialist/ Artwork Manager

We have an opportunity to work for our global animal health pharmaceutical client as a fully remote Quality Specialist – Artwork Manager. The role is a full-time PAYE temporary contract position initially signed off for 12 months with a possible extension and offers an hourly rate of £27.76 - £47.20 per hour, depending on experience, plus 25 days holiday pro rata and other benefits.

The purpose of the position is to manage the operational implementation of artwork changes for several small and large molecule external Contract Manufacturing Organizations (CMO’s) in the EU covering finished product packaging and quality as well as supply chain related adaptations. 

Due to the new Veterinary Regulation (EU) 2019/6 which became effective 28 January 2022 it is required to adapt the Summary of product characteristics (SPC) and subsequently the related artwork components to the new QRD 9.0 template to be finalized by 28 January 2027.

The job holder will be reporting to the External Manufacturing Quality (EMQ) EMEA Lead and being part of the multifunctional QRD team as a point of contact for products packaged at CMO’s and in close contact with the responsible project contact at the CMO.  Candidates should have a minimum of 3 years’ experience working within a similar Artwork Quality/GMP or Regulatory environment.

Role Functions & Responsibilities:

• Be the EMQ Site Point of Contact (SPOC) for the QRD 9.0 project
• Be in close contact with central Reliance QRD SPOC and in close contact with global Artwork department (GRA Operations)
• Be in close contact with the responsible project contact at the CMO
• Be the change task owner in Reliance (quality management system for change controls)
  • Take part in stakeholder meetings
  • Execution and timely closure of identified task
  • If applicable develop new technical specification with follow up actions
  • Execute the Quality Representative role
• Develop an artwork switch plan together with the global artwork department, the QRD Reliance Manager, the Global Supplier Management (GSM) contact and the project contact at the CMO for the impacted products 
• Escalate challenges and risks with respect to project timelines and resources to CMO Governance

Experience, Knowledge & Skills:

• Solid knowledge of the Good Manufacturing Practices (GMPs) in pharmaceutical industry.
• 3 Years’ experience in Quality/GMP or Regulatory environment.
• Solid knowledge about compliance requirements for change management and change control
• You are at ease with transversal projects
• Enjoy working in a dynamic & multicultural environment
• Enjoy working in a cross functional team and interact with various departments
• You speak English fluently
• Have good adaptability and integration skills
• Results oriented
• Experience with artwork management

Qualifications:

• Bachelor’s degree in science (Pharmacist, Engineer or equivalent) or something similar 
• Solid knowledge of the Good Manufacturing Practices (GMPs) in pharmaceutical industry
• Solid knowledge about compliance, regulatory or quality requirements in the pharmaceutical industry