Regulatory Compliance Specialist

2 days ago

Hyderabad Secunderabad Telangana, India beBeeQuality Full time
Job Title: Regulatory Compliance Specialist About the Role: 

In this pivotal role, you will oversee all production and testing activities to ensure seamless compliance with cGxP regulations. Your exceptional analytical skills will enable you to detect and address any discrepancies in data integrity and eCompliance.

You will be responsible for reviewing and approving production, QC, and AS and T records, as well as conducting MBR reviews. Your meticulous nature will help identify areas for improvement, supporting OpEx projects to drive innovation and efficiency.

A key aspect of this position is ensuring batch release compliance with registration, while maintaining a proactive approach to reporting technical complaints and adverse events related to Novartis products within 24 hours.

Your expertise will also extend to distributing marketing samples (where applicable), further solidifying your commitment to delivering high-quality results.

 Key Performance Indicators: 
  • On-time and GMP-compliant release of dosage forms
  • No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand
  • Successfully support continuous improvement projects
  • Executes batch release in compliance with registration
 Requirements: 

We are seeking an individual with:

  • Functional breadth and experience in QA/QC within the pharmaceutical or biotech industry
  • Prior exposure to environmental monitoring and collaborating across boundaries
  • A strong understanding of cleanliness zones and their significance

Your skills should include:

  • Continuous learning and adaptability
  • The ability to deal effectively with ambiguity
  • Proficiency in GMP procedures and quality control testing
  • Strong self-awareness and technological expertise
  • Familiarity with quality standards and technological intelligence

Languages :

  • English

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