Flexible QA Manufacturing Specialist - Real-Time GMP

Ten23 Health; Oberwallis; On-site; CHF 90,000 - 125,000; Full time

Benefits offered by this job

Annual bonus

Pension plan

Flexible working arrangements

Training options

Job summary

ten23 health is a human-centric partner for the pharmaceutical industry, seeking a dedicated QA Manufacturing Specialist to champion quality on the manufacturing shop floor. You will uphold GMP, verify critical process steps, and ensure every product meets our strict quality standards.

You will review batch records, observe aseptic practices if applicable, participate in audits, and coach operators to maintain a culture of quality.

Qualifications

• Strong background in quality assurance within pharmaceutical or regulated manufacturing.
• Solid understanding of GMPs and aseptic processing where applicable.
• Excellent communication and coaching skills to guide production teams.

Responsibilities

• Real-Time Shop Floor Oversight: provide on-the-floor QA support during manufacturing, cleaning, and environmental monitoring; witness critical process steps and IPCs.
• Line Clearance and Batch Execution: perform line clearances, review batch records, ensure proper labeling and material handling.
• Deviations and Issue Escalation: identify, report, and escalate deviations; coordinate with QA and production leadership for resolution.
• Batch Record Review and GMP Documentation: review and correct batch records; verify logbooks and cleaning records on the shop floor.
• Interventions and Aseptic Practices support (if applicable): observe aseptic operations for compliance; support gowning and cleanroom behavior.
• Routine Checks and Audits: conduct walkthroughs and participate in internal audits and regulatory inspections.
• Shop Floor Training and Coaching: provide on-the-job GMP guidance to operators and technicians.
• Investigations and CAPAs: contribute to root cause analyses and support corrective actions on shop-floor findings.

Skills

GMP knowledge

Quality assurance

GxP compliance

Communication

Team coaching

Job description

ten23 health is a human-centric partner for the pharmaceutical industry, seeking a dedicated QA Manufacturing Specialist to champion quality on the manufacturing shop floor. You will uphold GMP, verify critical process steps, and ensure every product meets our strict quality standards.

You will review batch records, observe aseptic practices if applicable, participate in audits, and coach operators to maintain a culture of quality.