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

ten23 health; Oberwallis; Presencial; CHF 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible work arrangements

Training & development

Annual bonus

Pension plan

Descripción de la vacante

ten23 health is seeking a QA Manufacturing Specialist to champion GMP on the shop floor. You will lead quality assurance during manufacturing, oversee line clearances, IPCs, and batch-record reviews to ensure product integrity.

Ideal candidates bring strong GMP QA experience in pharma manufacturing, knowledge of aseptic processes, and excellent coaching skills to guide production teams toward high quality and compliant operations.

Formación

• Strong background in quality assurance within pharmaceutical or regulated manufacturing.
• Good understanding of aseptic process and its core requirements.
• Excellent communication and coaching skills to guide production teams and reinforce quality culture.
• Ability to manage deviations in a fast-paced setting.

Responsabilidades

• Real-Time shop floor oversight during manufacturing, cleaning, and environmental monitoring operations.
• Observe GMP practices during critical steps and verify process controls and line clearance.
• Identify and report deviations, support impact assessment, and coordinate with QA and production leadership.
• Review batch records for accuracy, ensure proper GMP documentation, and support logbooks and equipment records.
• Observe aseptic interventions for contamination control and support gowning and cleanroom practices.
• Conduct routine walkthroughs and internal audits, providing on-the-floor knowledge and documentation.
• Provide on-the-job GMP coaching to operators and reinforce GDP practices.
• Support investigations and CAPAs with root-cause input and action follow-up.

Conocimientos

GMP knowledge

QA on manufacturing floor

Aseptic processing

Deviation management

Documentation & GDP

Coaching production teams

Descripción del empleo

About Us

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.

Your mission

We are looking for a dedicated QA Manufacturing Specialist 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.

Your responsibilites will include,

1. Real-Time Shop Floor Oversight

• Perform on-the-floor quality assurance support during manufacturing, cleaning, and environmental monitoring operations.
• Monitor adherence to GMP practices during critical manufacturing steps (e.g., line clearance, material dispensing, equipment setup).
• Witness and verify critical process steps, in-process controls (IPCs), and reconciliations.

2. Line Clearance and Batch Execution Monitoring

• Perform and document line clearances before manufacturing operations.
• Review manufacturing processes in real time for compliance with approved batch records and SOPs.
• Ensure proper material handling, labeling, and segregation during production.

3. Deviations and Issue Escalation

• Identify and report deviations or abnormal events on the shop floor.
• Support or lead immediate impact assessment and documentation of on-the-floor deviations.
• Ensure timely escalation and coordination with QA and production leadership for resolution.

4. Batch Record Review and GMP Documentation

• Review completed batch manufacturing records for accuracy, completeness, and compliance.
• Ensure timely corrections to documentation issues and assist operators in proper GMP documentation practices.
• Verify logbooks, equipment use records, and cleaning records on the shop floor.

5. Support for Interventions and Aseptic Practices (if applicable)

• Observe and assess interventions during aseptic operations for compliance with aseptic technique and contamination control.
• Support environmental monitoring activities, gowning practices, and cleanroom behavior compliance.

6. Participation in Routine Checks and Audits

• Conduct routine walkthroughs and spot checks to assess compliance with housekeeping, gowning, and other GMP standards.
• Participate in internal audits and regulatory inspections as needed, providing on-the-floor knowledge and documentation.

7. Shop Floor Training and Coaching

• Provide on-the-job coaching and GMP guidance to operators and technicians.
• Reinforce good documentation practices (GDP) and quality culture.

8. Support for Investigations and CAPAs

• Provide input into root cause analysis based on first-hand observations.
• Support implementation and follow-up of corrective and preventive actions directly related to shop floor findings.

Your profile

We are looking for someone with,

• A strong background in quality assurance within a pharmaceutical or regulated manufacturing environment, with a solid understanding of GMP (Good Manufacturing Practices).
• Good understanding of aseptic process and its core requirements
• Excellent communication and coaching skills to effectively guide production teams and reinforce a culture of quality.
• The ability to make sound decisions and manage deviations in a fast-paced setting.
• A collaborative spirit and a genuine passion for ensuring compliance and product integrity.

Why us?

We offer a dynamic environment where you can contribute meaningfully, collaborate with exceptional minds, and unlock your full potential.

Here’s what sets ten23 apart:

• A valuable and impactful career development opportunity in an inspiring environment
• Flexible working arrangements and environment with an open culture and diverse workforce
• The opportunity to work with and learn from highly qualified and experienced employees
• Our learning and self-developing culture offers a wide range of training options
• Competitive pension fund plan, annual bonus, and other financial and non-financial benefit

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.

Contact

For more information and clarification, please connect with Amrith ([e-mail]) from our Talent team!