Senior Specialist

3 weeks ago


Hyderabad, Telangana, India Smart IMS Inc. Full time

Job Title: Senior Specialist

Job Summary

Smart IMS Inc. is seeking a motivated Senior Specialist to join our team. The ideal candidate will have a strong background in Quality Assurance and Computer System Validation (CSV) within the life sciences industry.

Key Responsibilities

  1. Assist in the planning, execution, and management of CSV projects.
  2. Prepare and review validation documentation, including URS, FS, IQ, OQ, PQ, validation plans, and reports.
  3. Conduct validation activities to ensure compliance with GxP, FDA, and other relevant regulatory requirements.
  4. Collaborate with cross-functional teams, including IT, QA, and operations, to ensure seamless implementation of validated systems.
  5. Participate in risk assessments and gap analysis for computerized systems to ensure continuous compliance.
  6. Ensure adherence to validation protocols, documenting any deviations and corrective actions.
  7. Hands-on experience with validation software applications.

Requirements

  • Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field.
  • 2-5 years of experience in Quality Assurance and CSV within the life sciences industry.
  • Familiarity with regulatory guidelines (GxP, FDA, EMA, etc.) and validation standards.
  • Experience with validation software tools, automated testing, and risk management processes.
  • Strong understanding of QMS and compliance frameworks.
  • Knowledge of industry best practices in CSV documentation and procedures.
  • Experience in sales or business development in life sciences is a plus.
  • Life sciences industry experience is strongly preferred.

Benefits

  • Opportunity to work in a dynamic and growing company.
  • Collaborative and supportive team environment.
  • Professional development and growth opportunities.


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