QA Ops Specialist - GMP & Continuous Improvement

Proclinical; Hatfield; On-site; GBP 42,000 - 54,000; Full time

Job summary

Proclinical is seeking a QA Operations Specialist/Associate to support quality systems and assurance activities across the manufacture, packaging, testing, storage, and distribution of pharmaceutical products. You will ensure GMP compliance and contribute to continuous improvement while liaising with production teams in a fast-paced environment.

Your responsibilities include reviewing batch records, supporting audits, and aiding in CAPA implementation, change control, and training across the

Qualifications

• Basic knowledge of quality systems, GMP guidelines, and pharmaceutical manufacturing processes.
• Strong technical and scientific judgment to interpret data and present findings.
• Proficiency in Word, Excel, and PowerPoint.
• Effective communication, presentation, and time management skills.
• Ability to work collaboratively within a team and maintain professional behavior.
• Problem-solving and decision-making capabilities.

Responsibilities

• Serve as the quality point of contact for factory operations.
• Act as Quality Operations representative in production.
• Review and approve batch records and bulk batches.
• Support master batch records, SAP data, BOMs.
• Assist in review and approval of QC documentation.
• Draft and update SOPs for operational quality.
• Participate in audits and authority inspections.
• Investigate incidents and CAPAs.
• Support change control activities and training.
• Review qualification and validation protocols and reports.
• Contribute to technology transfer and new product introductions.
• Represent Quality Operations in risk assessments.
• Assist in recall testing and quality management reports.
• Maintain approved supplier lists and quality agreements.
• Identify continuous improvement opportunities for cost and efficiency.

Skills

Quality systems basics

Analytical thinking

MS Office

Communication skills

Teamwork

Problem solving

Tools

SAP

Job description

Proclinical is seeking a QA Operations Specialist/Associate to support quality systems and assurance activities across the manufacture, packaging, testing, storage, and distribution of pharmaceutical products. You will ensure GMP compliance and contribute to continuous improvement while liaising with production teams in a fast-paced environment.

Your responsibilities include reviewing batch records, supporting audits, and aiding in CAPA implementation, change control, and training across the