Key Compliance and Quality Expert

2 weeks ago

Mumbai, Maharashtra, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Title: Key Compliance and Quality Expert

Job Summary

This key role is responsible for ensuring compliance with regulatory standards across all API manufacturing sites. The Senior Manager will oversee quality management, facilitate reviews, and drive continuous improvement initiatives.

Main Responsibilities
  • Compliance and Quality Oversight
    • Critical Compliance Management: Ensure that all API sites adhere to cGMPs, GLPs, and regulatory requirements. Monitor vendor management, track compliance actions, and resolve escalated quality issues.
    • QMS Extension Optimization: Analyze QMS performance data to optimize extension and improve site efficiency.
    • Quality Management Reviews: Participate in site and corporate Quality Management Reviews (QMRs) and implement improvements to standardize processes across API sites.
    • Global Standards & Harmonization: Align site procedures with global quality standards and corporate policies.
  • Continuous Improvement Initiatives: Lead efforts to enhance compliance, efficiency, and cost-effectiveness through process improvements and metric monitoring.
  • Regulatory Audit Support: Assist internal and external audits, including remediation plan execution and effective observation resolution.

Required Skills and Qualifications

  • Qualification 1: Strong understanding of cGMPs, GLPs, and regulatory requirements.
  • Qualification 2: Proven experience in quality management, compliance, and continuous improvement.
  • Qualification 3: Excellent communication and leadership skills.

What We Offer

  • Benefit 1: Competitive compensation and benefits package.
  • Benefit 2: Opportunities for professional growth and development.
  • Benefit 3: Collaborative and dynamic work environment.

About Us

  • We Value: Integrity, teamwork, and customer satisfaction.

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