Conseiller/ère en systèmes d'application

We are looking for enthusiasts

KVALITO is a strategic partner and global quality and compliance services and network for regulated industries, with a prime focus on life sciences. Headquartered in Basel, Switzerland, we have subsidiar-ies in Germany, Czech Republic, Ireland, Italy, Spain and Malaysia. In our client's new organization, Digital and Operational Excellence, we aim to drive global development and execution of technical op-erations. By catalyzing the power of data and digital skills, we aspire to realize performance promises and deliver value to patients. Our leadership and consultants combine decades of experience in enter-prise environments. To cover all essential technical areas in the field of digital and mobile, KVALITO works with reliable Technology Partners worldwide. For more information, please visit us at www.KVALITO.ch

Life Science Consultant, Business System Owner (BSO)

Location: Germany
We are seeking a highly skilled and accomplished Life Science Consultant to join our team in Germany. The ideal candidate will have a proven track record of success in the life science industry, specializing in Quality and GMP Compliance, Computerized System Validation (CSV), and Supply Chain Management.
As a Business System Owner (BSO) for a leading pharmaceutical company, you will bring a wealth of expertise in regulatory compliance, project management, and innovation to ensure the success of criti-cal projects.

Major Accountabilities

1. Business System Ownership:
• Act as the BSO delegate, focusing on the implementation of production planning tools with-in the life science industry.
• Collaborate with stakeholders to gather and analyze business requirements for computer-ized systems, ensuring alignment with regulatory standards and industry best practices.
2. Validation Expertise:
• Develop comprehensive validation strategies, including risk assessments, validation plans, protocols, and reports, to ensure system integrity and compliance.
• Implement rigorous change control processes, assessing the impact of changes on comput-erized systems, and ensuring compliance with regulatory requirements.
3. Project Management:
• Lead and manage diverse high-value projects in the life science industry, demonstrating proficiency in Lean time management and quality management systems for cGMP-regulated environments.
• Enhance team control and structure through the implementation of project management tools.
4. Regulatory Compliance:
• Utilize in-depth knowledge of industry regulations and standards, ensuring compliance with quality and GMP requirements. Proficient in FDA and EMA guidelines.
5. Innovation and Problem-Solving:
• Demonstrate creative problem-solving skills, aligning innovative solutions with rigorous regulatory frameworks, including GxP requirements.
• Continually hone analytical, management, and communication skills.

Minimum Qualifications and Experience

Education

• Master's Degree in Sciences or Biotechnology.

Language

• Fluent in English
• Fluent in Spanish
• Fluent in Italian
• Additional European language expertise is an advantage

Work experience

• At least 5 years of practical experience as Technical lead of a pharmaceutical plant

Skills

• Knowledge of relevant industry standards & methods (ISO (ISO-9001 and 14971), ICHQ, GxP, Qualification and Validation, Quality Management, QMS, Process Management, Lean Management, Risk Management, Change Management, Quality and Project Management, Audit)
• Basic project management, good organization, and planning skills
• Knowledge of CSV, Quality and GMP Compliance, Supply Chain Management, Innovation, Master Data Management, IT Project Management, Quality Assurance, Audit, Training, Risk Management, Change Control, Plant Design, Process Validation and Root Cause Analysis.
• Good analytical skills
• Effective Communication
• Demonstrates problem-solving and idea-generation skills

We offer great benefits

• Flat hierarchies and responsibility from the beginning
• People-oriented culture
• Diversity and inclusion-focused environment
• Global client projects in a multinational environment
• Flexible working hours and home office
• Involvement in global conferences
• Individual professional development, training, and coaching
• Unlimited full employment contract
• Excellent remuneration package consisting of a competitive salary plus a substantial bonus

Contact

If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to recruiting(at)kvalito.ch including your:
• CV, cover letter and supporting documents (i.e., diplomas, certificates, references)
• Availability - earliest start date
• Salary expectations
• Location preference

We are looking forward to your application.

Your KVALITO Team.

Nos offres d'emploi s'adressent toujours à toutes les personnes capables de travailler, quels que soient leur âge, leur sexe, leur origine, leur orientation sexuelle, leur handicap, leur religion et leur idéologie, etc. Les candidats sont exclusivement sélectionnés sur la base de leurs qualifications. Les erreurs dans les informations données et l'orthographe sont réservées.