QA Operations Specialist/Associate

Proclinical; Schweiz; On-site; CHF 90,000 - 120,000; Full time

Job summary

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. You will ensure compliance with GMP standards and drive continuous improvement within operations.

Responsibilities include serving as the quality contact for factory departments, reviewing batch records, participating in audits, and contributing to risk assessments and CAPA activities.

Qualifications

• Basic knowledge of quality systems, GMP guidelines, and pharmaceutical manufacturing processes.
• Ability to interpret complex data and present findings effectively.
• Proficiency with MS Word, Excel and PowerPoint for documentation and reporting.

Responsibilities

• Serve as the quality point of contact for factory operations, assisting with quality records within the QMS.
• Act as the Quality Operations representative within production operations.
• Review and approve batch records, intermediate products, and bulk batches for in-house and third-party manufacturing.
• Assist in the review and approval of QC documentation and related SOPs.
• Participate in internal and external audits and competent authority inspections.
• Investigate incidents, deviations, and customer complaints, 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.

Skills

Quality systems knowledge

GMP guidelines

Pharma manufacturing processes

Analytical skills

Effective communication

Time management

Team collaboration

Problem solving

Decision making

Tools

Microsoft Word

Microsoft Excel

PowerPoint

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.