QA Operations Specialist/Associate

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

Join a quality-driven team where your expertise will help safeguard product quality, support operational excellence, and drive continuous improvement across pharmaceutical operations.

Proclinical is seeking a QA Operations Specialist/Associate to support quality systems and assurance activities related to the manufacture, packaging, testing, storage, and distribution of pharmaceutical products. This role focuses on ensuring compliance with GMP standards, quality systems, and industry regulations. You will play a key part in maintaining operational excellence and supporting continuous improvement initiatives.

Responsibilities:

• Serve as the quality point of contact for factory operational departments, assisting with quality records within the company QMS.
• Act as the Quality Operations representative within production operations.
• Review and approve batch records, intermediate products, and bulk batches for both in-house and third-party manufacturing.
• Support the approval of master batch records, SAP material master data, bills of materials, and other SAP-related processes.
• Assist in the review and approval of QC documentation.
• Draft and update SOPs related to operational quality activities.
• Participate in internal and external audits, as well as competent authority inspections.
• Investigate incidents, deviations, and customer complaints, including raising CAPAs and conducting assessments.
• Support change control activities and provide training on quality systems to staff.
• Review qualification and validation protocols, reports, and associated documents.
• Contribute to technology transfer projects and new product introductions.
• Represent Quality Operations in risk assessments and continuous improvement projects.
• Assist in testing product recall procedures and generating quality management system indicator reports.
• Maintain approved supplier lists and oversee quality agreements.
• Identify and implement continuous improvement opportunities for cost savings and efficiency.

Key Skills and Requirements:

• Basic knowledge of quality systems, GMP guidelines, and pharmaceutical manufacturing processes.
• Strong technical and scientific judgment with the ability to interpret complex data and present findings effectively.
• Proficiency in computer applications such as 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.

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