Senior Specialist

20 hours ago

Mangalore, Karnataka, India beBeeValidation Full time ₹ 9,00,000 - ₹ 15,00,000
Job Summary:

We are seeking a skilled and detail-oriented specialist to join our organization. In this role, you will be responsible for developing, executing, and maintaining validation protocols and documentation to ensure compliance with regulatory standards.

The ideal candidate will collaborate with cross-functional teams, contribute to audits and inspections, and provide expert guidance on validation processes. This position plays a key role in maintaining the quality and compliance of our systems.

Key Responsibilities:
  1. Develop and Maintain Validation Protocols
  2. Collaborate with Cross-Functional Teams
  3. Prepare and Update Technical Documentation
  4. Execute Validation Activities
  5. Support Audits and Regulatory Inspections
  6. Stay Updated with Industry Regulations
  7. Train Internal Teams
  8. Drive Continuous Improvement Efforts
  9. Maintain Accurate Records
  10. Provide Expert Guidance
Requirements:
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • Proven experience in validation within regulated industries like pharmaceuticals or healthcare.
  • Strong understanding of GxP compliance, FDA, EMA guidelines, and related industry standards.
  • Exceptional communication skills with the ability to produce clear, concise, and structured documentation.
  • Detail-oriented, with excellent analytical and problem-solving skills.
  • Capable of working independently as well as collaboratively in a team environment.
  • Flexibility to travel for client visits or perform remote work as needed.

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