Aseptic QA Engineer – Fill & Finish (GMP)

TechFirm Engineering; Basel; On-site; CHF 90,000 - 130,000; Full time

Job summary

Techfirm Engineering is seeking an experienced QA Engineer – Fill & Finish (m/f/d) to provide Quality Assurance support for sterile pharmaceutical manufacturing in Switzerland. The role focuses on aseptic Fill & Finish operations, ensuring GMP compliance and collaboration with Production, QC Microbiology, Engineering and Validation teams.

Responsibilities include reviewing batch records and SOPs, supporting deviation investigations, CAPAs, and change controls, and contributing to continuous

Qualifications

• Degree in Pharmacy, Biotechnology, Process Engineering, Chemistry or a related field.
• At least 5 years of QA experience in the pharmaceutical industry, especially sterile manufacturing.

Responsibilities

• Provide QA support to sterile manufacturing activities, especially aseptic Fill & Finish.
• Oversee manufacturing activities and review GMP docs on the shop floor.
• Ensure compliance with EU GMP Annex 1 and CCS requirements.
• Investigate deviations, perform root cause analyses and contribute to CAPAs.
• Participate in change controls and assess impact on product quality.

Skills

QA Oversight

GMP Compliance

Aseptic Processing

Root Cause Analysis

CAPA

Education

Pharmacy or related field

Sterile manufacturing experience

Tools

GMP Documentation Review

Job description

Techfirm Engineering is seeking an experienced QA Engineer – Fill & Finish (m/f/d) to provide Quality Assurance support for sterile pharmaceutical manufacturing in Switzerland. The role focuses on aseptic Fill & Finish operations, ensuring GMP compliance and collaboration with Production, QC Microbiology, Engineering and Validation teams.

Responsibilities include reviewing batch records and SOPs, supporting deviation investigations, CAPAs, and change controls, and contributing to continuous