Senior Compliance Specialist

3 days ago

Ajmer, Rajasthan, India beBeeQuality Full time ₹ 30,00,000 - ₹ 40,00,000

Job Summary

This role involves reviewing and approving batch manufacturing records, batch packaging records, and product label templates to ensure accuracy and compliance with regulations.

  • The incumbent will also coordinate with on-site teams to resolve discrepancies and missing documentation before batch release.
  • A key responsibility is monitoring electronic in-process control data, critical process parameter logs, and environmental monitoring results.
  • Additionally, the successful candidate will compile and analyze data for quality reports, identify trends or recurring issues, and prepare summaries for cross-functional teams.
  • They will assess and approve change control proposals, evaluating potential impacts on validation and regulatory compliance.
  • Lastly, they will conduct remote review of deviation reports, root cause analyses, and corrective action proposals.

Key Responsibilities:

  • Review and approve batch manufacturing records, batch packaging records, and product label templates to ensure accuracy and compliance with regulations.
  • Coordinate with on-site teams to resolve discrepancies and missing documentation before batch release.
  • Monitor electronic in-process control data, critical process parameter logs, and environmental monitoring results.
  • Compile and analyze data for quality reports, identify trends or recurring issues, and prepare summaries for cross-functional teams.
  • Assess and approve change control proposals, evaluating potential impacts on validation and regulatory compliance.
  • Conduct remote review of deviation reports, root cause analyses, and corrective action proposals.

Requirements:

  • Strong analytical and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage cross-functional teams and prioritize tasks.
  • Proficiency in QMS tools and software.

Education and Qualifications:

  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.

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