GMP QA Specialist — Shop Floor & Aseptic Compliance

Ten23 Health

Oberwallis

Remote

CHF 90,000 - 130,000

Full time

6 days ago
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Benefits offered by this job

Flexible working arrangements
Diverse workforce
Training options
Annual bonus

Job summary

ten23 health is seeking a QA Manufacturing Specialist to be the quality champion on the manufacturing shop floor, upholding GMPs and ensuring every product meets our strict quality standards.

You will oversee real-time operations, perform line clearances, document batch execution, review records, and coach operators in GDP and quality practices, contributing to a compliant, safe manufacturing environment in Switzerland.

Qualifications

  • Strong background in quality assurance within pharmaceutical or regulated manufacturing environments.
  • Solid understanding of GMP (Good Manufacturing Practices).
  • Good understanding of aseptic processes and core requirements.
  • Excellent communication and coaching skills to guide production teams and reinforce quality culture.
  • Ability to make sound decisions and manage deviations in a fast-paced setting.

Responsibilities

  • Real-Time Shop Floor Oversight during manufacturing, cleaning, and environmental monitoring.
  • Line Clearance and Batch Execution Monitoring with documentation.
  • Deviations and Issue Escalation, with on-the-floor assessment and escalation.
  • Batch Record Review and GMP Documentation across batch records and logs.
  • Support for Interventions and Aseptic Practices as applicable.
  • Participation in Routine Checks and Audits, including internal audits and inspections.
  • Shop Floor Training and Coaching on GDP and quality culture.
  • Support for Investigations and CAPAs with root cause input and action follow-up.

Skills

Quality assurance
GMP knowledge
Aseptic processes
Communication skills
Coaching
Deviations management

Job description

ten23 health is seeking a QA Manufacturing Specialist to be the quality champion on the manufacturing shop floor, upholding GMPs and ensuring every product meets our strict quality standards.

You will oversee real-time operations, perform line clearances, document batch execution, review records, and coach operators in GDP and quality practices, contributing to a compliant, safe manufacturing environment in Switzerland.

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