Senior Validation Consultant

hace 3 días


Xico, México Novartis A tiempo completo

Novartis is seeking a highly skilled Senior Validation Consultant to join our team in Mexico. As a key member of our Operations division, you will play a vital role in ensuring the quality and compliance of our computer systems.

About the Role:

  • Contribute to the improvement of local business processes, products, services, and software through data analysis.
  • Engage with business representatives and support the development of business requirements and deliver data-driven recommendations to improve efficiency and add value.
  • Participate in projects and operational changes to ensure that the creation of qualification documentation is in compliance with Novartis standards and procedures.
  • Create/Update CSV deliverables for OT systems as per Novartis procedures.
  • Advise and direct site teams on industry best practices for the development of CSV protocols, including risk assessments, user requirements, functional specifications, and test qualifications.
  • Collaborate with Quality Assurance and e-Compliance teams to ensure that CSV activities are in compliance with Novartis procedures.

Key Performance Indicators:

  • Feedback on dedicated phases for project execution (quality, time) - Degree of customization vs configuration of COTS solutions.
  • Process efficiency (specific scope) - Steady/Uninterrupted process flow (specific scope) - Completeness and accuracy of Business Process Model (BPM) - Local or non-complex processes - Business process documentation up to date (specific scope).

Requirements:

  • Bachelor's degree in Computer Science, Engineering, or a related field. Master's degree preferred.
  • Minimum of 10 years of experience in computer system validation, with a focus on process automation systems.
  • In-depth knowledge of regulatory requirements (e.g., FDA, GxP, 21 CFR Part 11) and industry best practices related to CSV.
  • Excellent problem-solving and analytical skills, with the ability to identify and resolve complex CSV issues.
  • Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and stakeholders at all levels of the organization.
  • Detail-oriented mindset, with a focus on accuracy and compliance.
  • Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.

The estimated annual salary for this position is around $85,000-$110,000, depending on experience. If you're passionate about delivering high-quality results and working in a collaborative environment, we encourage you to apply for this exciting opportunity.



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