Quality Assurance Eqmnt Qualif Expert

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

An exciting new opportunity has arisen to join us as
**Quality Assurance Qualification & Validation Engineer **for our Biotech drug substance plant in Corsier s/ Vevey.

As an integral member of the Quality Unit, you provide QA expertise for Equipment Qualification (including Sterilization qualification), Process Validation, Cleaning Validation, Raw Material Qualification and Computerized System Validation.

The role consists to elaborate the qualification/validation strategies, review and approval of protocols and reports, participates to risk analysis, identifies gap and purposes remediation plan. You act as Quality Subject Matter Expert on specific topics and participate inrisk assessments and handle deviations on these topics. You review and/or approve qualification/validation documents, risk assessment, SOPs and take quality decisions according to company standards.

The activities of the QA Expert cover all qualification/validation phases from Basic Design until 1st use of equipment/raw material.10. You ensure GMP compliance during all phases of qualification/validation.

**Who you are**:

- University or relevant engineering degree
- Hands on experience of equipment Qualification/Validation in the pharmaceutical industry
- At least 10 years' experience in a quality environment in pharmaceutical industry or equivalent
- Knowledge in cGMP and health authority expectations
- Knowledge in Data Integrity will be a plus
- Experience in Equipment(Utilities/E&M/Production/Lab equipment)
- Good interpersonal skills, with a positive attitude and the ability to support his colleagues in a context of growth and changes
- Good writing skills.
- French & English written & spoken.

**What we offer**: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.

We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.

We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.

Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life

Numéro de demande de recrutement: 249473

Lieux: Corsier-sur-Vevey

Expérience Professionnelle: D - Professional (4-9 years)

Modèle de temps de travail: Temps plein

**North America Disclosure**

**Segment de l'offre d'emploi**:QA, Quality Assurance, Pharmaceutical, Developer, Quality, Technology, Science

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