GMQA-0, Senior Expert, Digital Quality

Merck Group; Corsier-sur-Vevey; Vor Ort; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

A leading company in the industry is looking for a QA CQV Expert to enhance its quality management systems. The role requires managing compliance with health authorities and Merck standards, while fostering a culture of quality excellence. The ideal candidate will have deep knowledge in quality assurance and regulatory requirements, alongside strong leadership and communication skills.

Qualifikationen

• 8-10 years of work experience in quality assurance, quality management.
• Fluency in English, knowledge of French is a plus.
• Comprehensive knowledge of CSV and Data Integrity requirements.

Aufgaben

• Maintain and enhance the quality management system for Computerized Systems Validation.
• Review and approve GxP documents related to IT projects.
• Collaborate with project teams to ensure compliance with quality specifications.

Kenntnisse

Quality assurance

Quality management

IT compliance

Computer system validation

Data Integrity

Regulatory requirements

Attention to detail

Communication skills

Ausbildung

Graduate degree

Jobbeschreibung

Work Location: Corsier-sur-Vevey, Vaud
Shift: No
Department: HC-GM-QHAB BDC QA CQV
Recruiter:Clelia Liberatore

This information is for internals only. Please do not share outside of the organization.

YOUR ROLE:

We are excited to announce a fantastic opportunity for the position of QA CQV Expert! This role is a key part of our dynamic environment, leading the way in innovation and digitalization within the industry. You will be responsible for maintaining and enhancing the quality management system related to Computerized Systems Validation (CSV) and Data Integrity, ensuring that our site complies with Health Authorities' requirements and Merck Quality Standards for computerized systems implementation.

In this role, you will work closely with the Digital and Quality Assurance project teams to ensure that all deliverables meet quality specifications. You will be involved in the review and approval of GxP documents, including User Requirement Specifications (URS), traceability matrices, risk assessments, drawings, procedures, and qualification and validation documents. This is a unique opportunity to promote continuous improvement and drive innovative solutions in a supportive and collaborative environment.

We are looking for a passionate leader who can inspire a culture of quality excellence throughout our site.

YOUR PROFILE:

• Graduate degree with substantial to extensive professional experience in relevant fields (mature professional).
• Senior knowledge and experience in your discipline and beyond, with at least 8-10 years of work experience in quality assurance, quality management, IT compliance, or related areas.
• Proficiency and comprehensive knowledge of computer system validation (CSV) and Data Integrity requirements as defined by applicable health authorities and industry groups.
• In-depth understanding of quality management and CSV aspects (cGxPs, 21 CFR Part 11, Annex 11, GAMP) related to computer system applications.
• Thorough knowledge of regulatory requirements (FDA, EMEA, ICH).
• Strong attention to detail and excellent organizational skills.
• Autonomous, organized, and quality-driven with effective communication skills.
• Results-oriented with a strong focus on customer and quality.
• Fluency in English is mandatory; knowledge of French is a plus.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.