Senior Director of Quality Assurance and Compliance

3 days ago

Amrāvati, Maharashtra, India beBeeQuality Full time ₹ 1,80,00,000 - ₹ 2,52,00,000
Job Title: Head of Quality Assurance

Job Description:

As a seasoned professional, you will be responsible for overseeing the development and implementation of quality management systems to ensure that our products meet the highest standards. You will lead a team of experts in auditing and compliance to guarantee regulatory requirements are met.

Key Responsibilities:

  • Develop, implement, and maintain robust Quality Management Systems (QMS) ensuring compliance with GMP regulations and industry best practices.
  • Coordinate vendor qualification activities, internal audits, and CAPA close-outs to ensure seamless operations.
  • Oversee Qualified Person audits, Regulatory Inspections, and product recalls.
  • Develop and improve document control systems and processes to support efficient operations.
  • Establish and manage change management, deviation management, incident handling, and complaint resolution processes.
  • Lead quality training programs and oversee investigations of non-conformances.
  • Collaborate with cross-functional teams to ensure readiness for inspections by regulatory agencies.
  • Stay up-to-date on changes in quality regulations and guidelines, providing insights to the management team.
  • Manage data integrity audits, training, review, and reporting.
  • Ensure validation activities are performed according to approved protocols.
  • Advise on technology transfer documentation, records management, and transmission to meet regulatory requirements.
  • Maintain departmental operational performance, meeting requirements for regulatory authorities, SOPs, and external/internal customers.
  • Develop and approve SOPs, ensuring regulatory compliance and operational efficiency.
  • Implement self-inspection programs and review batch manufacturing/ packaging records.
  • Organize review meetings, document actions, and corrective measures for cGMP requirements.
  • Monitor IPQA activities, review, and report.
  • Prepare, review, finalize, and submit documents to external customers and agencies as needed.
  • Adhere to Validation master plans and schedules.
  • Control sample management and stability management in conjunction with QC teams.
  • Conduct quality and management review meetings.
  • Oversee documentation cells and archival programs.
  • Manage artwork approval, shade card maintenance, label management, and risk management.
  • Review pest control management, fire extinguisher annual documents, and water system validation documents.
  • Conduct transport validation and national/international manufacturing licensing activities.
  • Negotiate and adhere to quality agreements and vendor agreements.
  • Coordinate dispatches of finished products per country-specific approvals.

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