Regulatory Compliance Specialist

5 days ago

Chennai, Tamil Nadu, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000
Regulatory Compliance Expert

About the Role:

We seek a highly skilled Regulatory Compliance Expert to ensure adherence to regulatory requirements and implement effective quality management systems.

Main Responsibilities:

  • Document Control: Prepare and review QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes.
  • Change Management: Review, approve, and trend Change Control (CC) records, assessing potential impact on validation, process performance, and regulatory compliance. Handle deviations by reviewing deviation reports, assessing adequacy of root cause analysis, recommending corrective/preventive actions, and ensuring timely closure in compliance with procedural requirements.
  • Market Complaint Resolution: Review and approve market complaint investigations, ensuring thorough root cause identification, adequacy of corrective/preventive actions, and compliance with regulatory timelines.
  • Critical Quality Incident Investigations: Review and approve investigation reports for OOS (Out-of-Specification), OOT (Out-of-Trend), and any critical quality incidents, ensuring accuracy, completeness, and regulatory compliance.
  • Vendor Quality Oversight: Manage vendor quality activities remotely, including review of vendor qualification/approval documentation, participation in vendor audits (virtual or on-site as required), and review of vendor audit reports.
  • QMS Performance Metrics and Reporting: Monitor and trend QMS performance metrics (e.g., CC closure rates, deviation frequency, CAPA on-time completion, vendor performance metrics) and prepare quarterly quality performance reports for management.

Key Skills and Competencies:

  • Aseptic Techniques and Sterile Injectables: In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Validation Methodologies and Regulatory Guidelines: Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
  • Analytical and Problem-Solving Skills: Strong analytical and problem-solving skills.
  • Communication and Documentation Skills: Effective communication and documentation skills.
  • Team Leadership and Prioritization: Ability to manage cross-functional teams and prioritize tasks.
  • QMS Tools and Software Proficiency: Proficiency in QMS tools and software.

Education and Qualifications:

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