QA Specialist Mat. Leave

1 mese 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:
**The Quality Assurance specialist will entail ensuring compliance with all regulatory and corporate requirements in support of regulatory, internal standard and customer expectations, by carrying out routine quality assurance and quality control tasks and activities.The Quality Assurance specialist will handle Deviations, CAPA, Product Alert, to ensure the systems compliance with all Domestic, Global regulatory and corporate requirements.The Quality Assurance specialist will conduct QA Oversignt (and audits to laboratories, development, warehouse and all Site Departments) to assure compliance to current standards/ISO and collaborate to resolve quality concerns, by fostering the implementation of quality improvements and by meeting with Managers, Supervisor to assure current methods, procedures or SOP’s meet current standards. Main responsibilities are: check department daily or weekly to control for the whole process; prepare the SOPs for quality management (Deviation, CAPA, Product Alert,etc..); review and approve the SOPs from other departments; review the validation and qualification document and Investigation of quality issue; deviation management; ensure to fulfill the KPIs of QA; actively participate in quality culture building and quality related activities; actively report quality related events and participate in continuous quality improvement activities; manage all quality audit aspects of Suppliers, Packagers, Distributors, Warehouses, Contract Laboratories as appropriate.

**Who you are:
- Minimum bachelor’s degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, or a related discipline
- At least 3 years of working experience in a pharmaceutical or biological GMP/ISO environment with GMP/ISO experience
- New project experience and build-up of quality management system are preferred
- Familiar with GMP regulations/guides and quality management process
- Fluent in English
- Result orientation, accuracy and reliability as a must Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability

**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


  • QA Specialist

    1 mese 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...