Quality Auditor - II - FSR Level - P2

Proclinical Group; Milton Keynes; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading life sciences recruiter is seeking a Quality Auditor to oversee artwork changes compliance for external Contract Manufacturing Organizations in the UK. The role involves ensuring adherence to new Veterinary Regulations and collaborating with various teams for timely project execution. Candidates should have a strong understanding of Good Manufacturing Practices and a bachelor's degree in a relevant field.

Qualifications

• Strong knowledge of pharmaceutical industry GMPs.
• Familiarity with compliance requirements for change management.
• Experience in Quality-GMP or Regulatory environments.

Responsibilities

• Act as the EMQ Site Point of Contact for the QRD 90 project.
• Collaborate with global artwork departments and GRA Operations.
• Manage change tasks within the quality management system.

Skills

Knowledge of Good Manufacturing Practices (GMPs)

Change management experience

Transversal project management

Results-oriented mindset

Fluent English

Education

Bachelor's degree in Science, Pharmacy, Engineering, or a related field

Job description

Proclinical is seeking a Quality Auditor to support the operational implementation of artwork changes for external Contract Manufacturing Organizations (CMOs) in the EU. This role focuses on ensuring compliance with the new Veterinary Regulation (EU 2019/6) and adapting product packaging and quality processes accordingly. You will work closely with cross-functional teams, including global artwork departments and CMOs, to manage change controls and ensure timely project execution.

Responsibilities:

• Act as the EMQ Site Point of Contact (SPOC) for the QRD 90 project.
• Collaborate with central Reliance QRD SPOC, global artwork departments, and GRA Operations.
• Serve as the primary liaison with project contacts at CMOs.
• Manage change tasks within the Reliance quality management system.
• Participate in stakeholder meetings and ensure timely task execution.
• Develop and follow up on new technical specifications as needed.
• Execute the Quality Representative role for assigned projects.
• Create artwork switch plans in collaboration with global teams and CMO contacts.
• Identify and escalate challenges or risks related to project timelines and resources.

Key Skills and Requirements:

• Strong knowledge of Good Manufacturing Practices (GMPs) in the pharmaceutical industry.
• Familiarity with compliance requirements for change management and control.
• Experience in Quality-GMP or Regulatory environments.
• Proficiency in managing transversal projects and working in multicultural, cross-functional teams.
• Fluent in English with excellent adaptability and integration skills.
• Results-oriented mindset with experience in artwork management.
• Bachelor's degree in Science, Pharmacy, Engineering, or a related field.

If you are having difficulty in applying or if you have any questions, please contact Numhom Sudsok at [e-mail].

Apply Now:

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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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