QA Operational Quality Specialist

5 mesi fa

Guidonia Montecelio, Italia Merck KGaA A tempo pieno

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

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.

**Your role:
You will be in responsible for developing and reviewing equipment/process validation projects with a quality focus and risk-based approach. You will interact on a daily basis and develop strong relationships with Operations and other key internal/external stakeholders. Expert with wide-ranging experience in developing, establishing and maintain quality validation methodologies, systems, and practices which meet regulatory requirements. Serves as a representative to improve awareness, visibility, communication on quality initiatives to support departmental, site and divisional quality goals and priorities such as s upport cost reduction projects, r eview validation strategy, protocols and reports with a risk-based approach, m anage project schedules with strict adherence to critical milestones, p roactively investigates, identifies, and implements best-in-class Quality practices, l ead/support in building quality related infrastructure, & instruments including preparation of URS, System Risk Assessment, and subsequent validation, r eview the Change Control system to determine the impact of proposed changes to the qualification status of equipment and processes, p erforming root cause analysis and corrective actions for process and equipment-related quality issues, s upports internal and external regulatory audits.

**Who you are:
- 3 years validation experience
- Minimum B.S. degree in scientific field
- Full understanding of product, equipment and process validation
- Strong written and verbal communication skills (internal/external)
- Strong teamwork and collaboration skills
- Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes Experienced with Quality & GxP IT compliance requirements

**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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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