Quality Specialist/ Artwork Manager

Room At The Top Recruitment; City Of London; Remote; GBP 60,000 - 80,000; Full time

Job summary

A global animal health pharmaceutical client is looking for a fully remote Quality Specialist Artwork Manager to oversee artwork changes in compliance with regulatory requirements. The role is a full-time PAYE temporary position for 12 months, offering an hourly rate of £27.76 - £47.20. Candidates should possess at least 3 years of experience in a similar role and hold a Bachelor's degree in science. Enjoy working in a dynamic multicultural environment and interact across various teams.

Benefits

25 days holiday pro rata

Competitive hourly rate

Dynamic multicultural environment

Qualifications

• Minimum of 3 years experience in Quality/GMP or Regulatory environment.
• Solid knowledge of compliance and regulatory requirements in the pharmaceutical industry.

Responsibilities

• Manage the operational implementation of artwork changes for CMOs.
• Act as the EMQ Site Point of Contact for the QRD 9.0 project.
• Develop an artwork switch plan and manage stakeholder communications.

Skills

Good Manufacturing Practices (GMP)

Artwork management

Compliance requirements

Transversal projects

Cross-functional teamwork

Fluent English

Results-oriented

Adaptability

Education

Bachelor's degree in science (Pharmacist, Engineer or equivalent)

Job description

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 (CMOs) 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 CMOs 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