Life Science Consultant, Validation Consultant

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Life Science Consultant, Validation Consultant (CHANDIGHAR, ), (MUMBAI, ), (HYDERABAD, ), (PUNE, ), (Bangalore, ), (Kochi, ), (Chennai, ), (Panaji, ), Andaman and Nicobar Islands, Andhra Pradesh, Assam, Bihar, Chandigarh, Dadra and Nagar Haveli, New Delhi, Gujarat, Haryana, Himachal Pradesh, Jammu and Kashmir, Kerala, Lakshadweep, Madhya Pradesh , Maharashtra, Manipur, Meghalaya, Karnataka, Nagaland, Odisha, Pondicherry, Punjab, Rajasthan, Tamil Nadu, Tripura, Uttar Pradesh, West Bengal, Sikkim, Arunachal Pradesh, Mizoram, Daman and Diu, Goa, Bihar, Madhya Pradesh, Uttar Pradesh, Chhattisgarh, Jharkhand, Uttarakhand, Telangana - India | Posted - 24/05/23 Overview

We are looking for enthusiasts

KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality. Headquartered in Basel, Switzerland, we have subsidiaries in Germany, Czech Republic, Ireland, Italy and Malaysia. With our enthusiasm for progressive technologies and our in-depth knowledge of industry best practices and regulations, we drive effective and efficient project delivery to keep our industry-leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise 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

Life Science Consultant, Validation Consultant Location: India, Remote We are seeking a Validation Consultant to aid with the validation process. The consultant will be responsible for ensuring standards and will contribute to the development of an ISO certification framework. The successful candidate should have experience in Agile CSV and IT Security, as well as knowledge of ISO standards, preferably ISO 27000/ISO 27001. This is a project-based role, and the consultant will collaborate with the development team based in India and the design team in Switzerland. Responsibilities:
• Initiate and manage the validation process for App Versions 2 and 3 of the client, ensuring compliance with CSV standards.
• Collaborate with the development and design teams to gather and document URS/User Stories, Product Specs, Architecture Design, and Detailed Design (Tasks).
• Oversee the execution of the validation process, including Development, Testing (IQ, OQ, UAT), and Backlog/Change Management.
• Conduct a gap analysis to identify areas of improvement for CSV, IT Security, and ISO certification frameworks.
• Develop a roadmap for implementing an ISO 27000 or ISO 27001 framework to ensure data security and compliance.
• Collaborate with stakeholders to define validation requirements, timelines, and deliverables for each version of the app.
• Ensure all relevant documentation is accurately stored in JIRA and approvals are conducted through DocuSign.
• Provide regular updates to the client, project team, and management regarding the progress of the validation process.
• Collaborate with internal teams and external consultants as needed to address technical challenges and ensure the successful completion of the project.
• Stay updated with industry best practices, regulations, and standards related to app validation, CSV, IT Security, and ISO certifications.
Minimum Qualifications and Experience
Education
• Bachelor’s degree in computer science, Engineering, or a related field.
Language
• Fluent in English, both written and spoken is a requirement
• Any additional language is a plus
Work Experience
• Minimum 5 years experience in Agile CSV and IT Security, preferably in the pharmaceutical industry.
Hard Skills
Must Have:
• Strong knowledge of ISO standards, particularly ISO 27000 and ISO 27001.
• Familiarity with JIRA and Confluence.
• Excellent project management and organizational skills.
• Experience in creating validation documentation, including URS/User Stories, Product Specs, and Detailed Design (Tasks).
• Previous experience with app validation and ISO certification frameworks is highly desirable.
Nice to Have:
• Certification in CISM/CISSIP
• ISO 13845 Medical Devices Quality Management Systems
• Strong knowledge in Data Privacy
• Experience in SaMD Class 1
Soft Skills
• Strong written and verbal communication skills
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills.
• Excellent people management, leadership, and decision-making skills.
• Ability to facilitate a holistic perspective and understand business needs.
• Ability to work independently and collaboratively in a cross-functional team environment.
• Motivated to continuously expand her/his knowledge of the life science industry.
• Strong communication and problem-solving skills.
• Ability to work globally to coordinate the work of associates at all levels.
• Considerable organization awareness (e.g., the interrelationship of departments, business priorities) including experience in working cross-functionally and in global teams across cultures.
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.