GMP QA Operations Specialist | Quality & Compliance

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

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.