Data Compliance Specialist

2 days ago

Kolkata, West Bengal, India beBeeCompliance Full time ₹ 8,00,000 - ₹ 15,00,000

**Job Opportunity:**

We are seeking a skilled and detail-oriented professional to fill a key role in our organization.

Job Description:

In this position, 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 Computer System Validation (CSV) processes.

Key Responsibilities:
  1. Develop and maintain CSV protocols and reports in compliance with FDA, EMA, and other regulatory requirements.
  2. Collaborate with cross-functional teams to ensure timely delivery of CSV documentation with high quality standards.
  3. Prepare and update user manuals, SOPs, and other technical documentation related to CSV processes.
  4. Execute CSV activities including risk assessments, validation testing, and documentation review.
  5. Support audits and regulatory inspections by providing relevant CSV documentation and participating in audit response efforts.
  6. Stay updated with evolving industry regulations and ensure company practices remain aligned with current best practices.
  7. Train internal teams and stakeholders on CSV processes and documentation expectations.
  8. Drive continuous improvement efforts to enhance CSV processes and document efficiency.
Requirements:
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • Proven experience in CSV 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.
Additional Information:

This is a great opportunity for individuals who are passionate about CSV and want to make a meaningful contribution to our organization.

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