Quality Assurance Expert

Vor 7 Tagen

CorsiersurVevey, Schweiz Merck KGaA Darmstadt Germany Vollzeit

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.

Are you a dynamic Quality Assurance Expert looking for an opportunity to be part of a project to build a State -Of-The-Art Biotech Development Facility in Switzerland? This facility is an exciting opportunity to work collaboratively with groups from all phases of development to establish a harmonious balance between the GXP and non-GXP worlds.

An exciting new opportunity has arisen to join the BDC team as a Quality Assurance Expert

As an integral member of the Quality Unit, you provide QA expertise for Warehouse Management, Raw Material Management and Biotech Manufacturing Compliance.

**Your Role **within the context of development and clinical manufacturing
***:
**Quality Assurance Expert for Operations**
- Oversee Compliance of the Warehouse & Manufacturing by reviewing data, deviations, and change controls
- Collaborate with other departments to create/review risk assessments
- Ensure OOS, deviation, change control processes are properly followed, provide QA decisions and approval for these exceptions. Ensure that investigations determine root causes, impact assessments and appropriate preventative/corrective actions. Ensure timely closure of investigations, and proper escalation to management as per local and global procedures.
- Monitor QA process and manage communication and reporting according to a defined frequency
- Support employee training to diffuse new regulations and policies
- Support audits and inspections as required
- Participate in improvement projects as a team member, as a team leader

**Who you are**:

- Degree in a Life Science or related discipline such as pharmacy, biochemistry, chemistry or other relevant (minimum MSc or equivalent degree),
- 5-10 years of experience in a pharmaceutical/biotechnology environment,
- Broad experience in working with other quality professionals in new product development and know-how of product launches in development,
- Strong interpersonal and leadership skills,
- Excellent communication skills
- Fluency in English (written and spoken), French is a plus
- Results driven with a strong customer and quality focus,
- Demonstrated ability to work in international, multi-cultural teams.
- Deep knowledge of Health Authority regulations
- Flexible team player, who is curious to learn, proactive in sharing and collaborating
- Thorough experience in the usage of Merck IT systems (mandatory: CARA and TW; beneficial: GxP Manager, GLIMS, SAP Lean, etc.)
- Strong analytical and problem-solving abilities
- Organized and logical in defining workload and delivering projects

**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

Job Requisition ID: 254347

Location: Corsier-sur-Vevey

Career Level: D - Professional (4-9 years)

Working time model: full-time

**North America Disclosure**

**Notice on Fraudulent Job Offers**
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.

**Job Segment**:QA, Quality Assurance, Pharmaceutical, Developer, Pharmacy, Quality, Technology, Science, Healthcare

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