Senior QA Engineer – Aseptic Fill & Finish

Tech'Firm Industrie AG; Basel; On-site; CHF 110,000 - 160,000; Full time

Job summary

Tech'Firm Industrie AG is seeking a QA Engineer – Fill & Finish (m/f/d) to provide QA support for sterile manufacturing operations near Basel, Switzerland. You will focus on aseptic Fill & Finish processes and ensure compliance with GMP requirements while collaborating with Production, QC Microbiology, Engineering and Validation teams.

Requirements include a Master’s degree, 5+ years in pharmaceutical QA, experience with aseptic manufacturing, and fluency in English (German advantageous).

Qualifications

• Degree or equivalent in Pharmacy, Biotechnology, Process Engineering, Chemistry or related field.
• 5+ years of QA experience in pharmaceutical industry, sterile manufacturing.
• Experience supporting/overseeing aseptic Fill & Finish operations.
• Strong knowledge of GMP, especially EU GMP Annex 1.
• Experience with batch record review, deviation management, root cause analysis, CAPA and change control.
• Isolator/RABS experience a plus; familiarity with Media Fill campaigns, validation and equipment qualification.

Responsibilities

• Provide operational QA support to sterile pharmaceutical manufacturing activities, especially aseptic Fill & Finish operations.
• QA oversight on shopfloor activities; review/approve GMP docs (BMR, SOPs, protocols, reports).
• Ensure compliance with EU GMP Annex 1 and CCS requirements.
• Support deviation investigations, root-cause analyses and CAPAs.
• Participate in change control activities and assess impact on product quality and GMP compliance.
• Collaborate with Production, QC Microbiology, Engineering and Validation teams for QA oversight.
• Support process validation and qualification activities, including Media Fill campaigns (APS).
• Participate in risk assessments and drive continuous improvement in sterile manufacturing.

Skills

GMP compliance

Root cause analysis

CAPA

Deviations management

Change control

Documentation review

Education

Master’s degree ( university of applied sciences )

Tools

Isolator

RABS

Job description

Tech'Firm Industrie AG is seeking a QA Engineer – Fill & Finish (m/f/d) to provide QA support for sterile manufacturing operations near Basel, Switzerland. You will focus on aseptic Fill & Finish processes and ensure compliance with GMP requirements while collaborating with Production, QC Microbiology, Engineering and Validation teams.

Requirements include a Master’s degree, 5+ years in pharmaceutical QA, experience with aseptic manufacturing, and fluency in English (German advantageous).