QA Manufacturing Lead, Visp e/v/e/r/y/o/n/e

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{
  "id": "2417259",
  "name": "QA Manufacturing Lead, Visp e/v/e/r/y/o/n/e",
  "office": "Visp",
  "keywords": [],
  "schedule": "full-time",
  "createdAt": "2025-11-05T13:08:15+00:00",
  "seniority": "experienced",
  "department": "Quality Assurance",
  "occupation": "operations_and_plant_management",
  "subcompany": "ten23 health Valais AG",
  "employmentType": "permanent",
  "jobDescriptions": [
    {
      "name": "About Us",
      "value": "ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients."
    },
    {
      "name": "Your mission",
      "value": "We are looking for a dedicated QA Manufacturing Lead to be our quality champion on the manufacturing shop floor. In this role, you will play a critical part in maintaining Good Manufacturing Practices (GMPs), ensuring that every product meets our rigorous quality standards.<br><br>Your responsibilites will include, <br><br>1. Real-Time Shop Floor Oversight<br><ul><li>Perform on-the-floor quality assurance support during manufacturing, cleaning, and environmental monitoring operations.</li><li>Monitor adherence to GMP practices during critical manufacturing steps (e.g., line clearance, material dispensing, equipment setup).</li><li>Witness and verify critical process steps, in-process controls (IPCs), and reconciliations.</li></ul>2. Line Clearance and Batch Execution Monitoring<br><ul><li>Perform and document line clearances before manufacturing operations.</li><li>Review manufacturing processes in real time for compliance with approved batch records and SOPs.</li><li>Ensure proper material handling, labeling, and segregation during production.</li></ul>3. Deviations and Issue Escalation<br><ul><li>Identify and report deviations or abnormal events on the shop floor.</li><li>Support or lead immediate impact assessment and documentation of on-the-floor deviations.</li><li>Ensure timely escalation and coordination with QA and production leadership for resolution.</li></ul>4. Batch Record Review and GMP Documentation<br><ul><li>Review completed batch manufacturing records for accuracy, completeness, and compliance.</li><li>Ensure timely corrections to documentation issues and assist operators in proper GMP documentation practices.</li><li>Verify logbooks, equipment use records, and cleaning records on the shop floor.</li></ul>5. Support for Interventions and Aseptic Practices (if applicable)<br><ul><li>Observe and assess interventions during aseptic operations for compliance with aseptic technique and contamination control.</li><li>Support environmental monitoring activities, gowning practices, and cleanroom behavior compliance.</li></ul>6. Participation in Routine Checks and Audits<br><ul><li>Conduct routine walkthroughs and spot checks to assess compliance with housekeeping, gowning, and other GMP standards.</li><li>Participate in internal audits and regulatory inspections as needed, providing on-the-floor knowledge and documentation.</li></ul>7. Shop Floor Training and Coaching<br><ul><li>Provide on-the-job coaching and GMP guidance to operators and technicians.</li><li>Reinforce good documentation practices (GDP) and quality culture.</li></ul>8. Support for Investigations and CAPAs<br><ul><li>Provide input into root cause analysis based on first-hand observations.</li><li>Support implementation and follow-up of corrective and preventive actions directly related to shop floor findings.</li></ul>"
    },
    {
      "name": "Your profile",
      "value": "We are looking for someone with, <br><ul><li>A strong background in quality assurance within a pharmaceutical or regulated manufacturing environment, with a solid understanding of GMP (Good Manufacturing Practices).</li><li>Good understanding of aseptic process and its core requirements</li><li>Excellent communication and coaching skills to effectively guide production teams and reinforce a culture of quality.</li><li>The ability to make sound decisions and manage deviations in a fast-paced setting.</li><li>A collaborative spirit and a genuine passion for ensuring compliance and product integrity.</li></ul><br>"
    },
    {
      "name": "Why us?",
      "value": "We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.<br> <br>Here's what sets ten23 apart:<br><ul><li>A valuable and impactful career development opportunity in an inspiring environment  </li><li>Flexible working arrangements and environment with an open culture and diverse workforce  </li><li>The opportunity to work with and learn from highly qualified and experienced employees  </li><li>Our learning and self-developing culture offers a wide range of training options  </li><li>Competitive pension fund plan, annual bonus, and other financial and non-financial benefit </li></ul>At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws."
    },
    {
      "name": "Contact",
      "value": "For more information and clarification, please connect with Amrith ([email protected]) from our Talent team!"
    }
  ],
  "occupationCategory": "production_and_operations",
  "recruitingCategory": "Permanent Employee"
}