Validation Specialist

3 days ago


Mumbai, Maharashtra, India Maxis Clinical Sciences Full time
About Maxis Clinical Sciences

We are a leading clinical sciences company seeking an experienced Validation Specialist to join our team. As a key member of our quality assurance department, you will play a vital role in ensuring the compliance of our computerized systems with GxP regulations.

Job Summary

The successful candidate will be responsible for developing and executing validation strategies, protocols, and documentation plans for our GxP-regulated environments. This includes installing, operating, and maintaining computerized systems, as well as performing risk assessments and collaborating with internal stakeholders to coordinate validation activities.

Key Responsibilities
  • Develop validation strategies, protocols, and documentation plans for computerized systems used in GxP-regulated environments;
  • Execute validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ);
  • Perform risk assessments to identify critical processes and parameters and ensure appropriate controls are implemented;
  • Collaborate with internal stakeholders to coordinate validation activities;
  • Review and approve validation documentation, ensuring compliance with regulatory requirements and internal quality standards;
Requirements
  • Strong understanding of GxP regulations, including GDP, GLP, GMP, and GCP requirements, as well as validation principles and methodologies;
  • Familiarity with risk assessment techniques and their application to validation activities;
  • Excellent analytical and problem-solving skills, with the ability to identify and address complex validation issues effectively;
  • Strong communication and interpersonal skills, with the ability to collaborate with cross-functional teams and communicate technical information clearly and concisely;
Benefits

We offer a competitive salary package, including a base salary of $120,000 per year, as well as benefits such as health insurance, retirement plan, and paid time off. We also offer opportunities for professional growth and development, including training and certification programs.


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