Quality Specialist

Quanta Consultancy Services Ltd; Bedford; On-site; GBP 45,000 - 60,000; Full time

Job summary

A leading pharmaceutical firm in Bedford is seeking a Quality Specialist to manage the operational implementation of artwork changes for external Contract Manufacturing Organisations. The ideal candidate will have extensive experience in a Quality or Regulatory environment, solid knowledge of compliance requirements, and experience with artwork management. This role offers an initial 11-month contract in a dynamic industry setting.

Qualifications

• Extensive experience in a Quality/GMP or Regulatory environment.
• Solid knowledge of compliance requirements for change management and change control.
• Experience with artwork management.

Responsibilities

• Manage the operational implementation of artwork changes for several CMOs.
• Report to the External Manufacturing Quality (EMQ) EMEA Lead.
• Develop an artwork switch plan with multiple stakeholders.
• Escalate challenges and risks regarding project timelines and resources.

Job description

Quality Specialist - UK, Bedford - 11 Months Initial Contract

Do you want to be involved with exciting pharmaceutical projects?

When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Quality Specialist.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:

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

Desirable Experience:

• Requires extensive experience in a Quality/GMP or Regulatory environment.
• You have a solid knowledge of compliance requirements for change management and change control
• Experience with artwork management

If this role is of interest to you, please apply now!
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