Director of Quality Systems

5 days ago

Tiruchi, Tamil Nadu, India beBeeQuality Full time ₹ 25,00,000 - ₹ 35,00,000
Job Title: Quality Assurance Director

The ideal candidate will have a strong background in quality assurance, with experience in implementing and maintaining quality systems. The individual should be well-versed in regulatory standards and guidelines, and have excellent leadership and communication skills.


Key Responsibilities:
  • Develop, implement, and maintain quality audit processes and GMP systems to ensure compliance with regulatory requirements.
  • Coordinate vendor qualification activities, internal audits, compliance audits, and Qualified Person audits to ensure the highest level of quality.
  • Responsible for CAPA close-out and document control system to maintain accuracy and integrity.
  • Establish a robust Quality Management System (QMS) to manage change management, deviation management, incidents, complaint handling, and CAPA management.
  • Provide quality guidance to product development projects and programs to ensure alignment with company standards.
  • Ensure data integrity and conduct internal audits, training, and review to maintain a high level of quality.
  • Maintain and improve departmental operational performance to meet regulatory requirements and company SOPs.
  • Review, approve, and issue batch manufacturing records and packaging records to ensure accuracy.
  • Monitor IPQA activities and report findings to identify areas for improvement.
  • Responsible for adherence to validation master plans and schedules to ensure compliance.
  • Control sample management and stability management to ensure accurate results.

Additional Responsibilities:
  • Lead and manage change management programs throughout the organization to ensure seamless implementation.
  • Keep abreast of changes to quality regulations and guidelines, advising the management team of business implications to inform strategic decisions.
  • Conduct transport validation and review documents with the engineering department to ensure alignment with company standards.
  • Manage national and international manufacturing licensing activities with the regulatory affairs team to ensure compliance.
  • Develop and maintain a system to implement ICH Q8, Q9, and Q10 requirements to ensure alignment with industry standards.

Requirements:
  • Well-versed in GMP, regulatory standards, and quality systems to ensure a high level of quality.
  • Experience in quality assurance, compliance, and auditing to ensure effective implementation of quality systems.
  • Strong leadership and communication skills to effectively lead and manage teams.

Working Across Disciplines:
  • Collaborate with manufacturing, warehouse, and QC teams to ensure regulatory readiness and alignment with company standards.

Keeping Up-to-Date:
  • Stay current with changes to quality regulations and guidelines to inform strategic decisions and ensure compliance.

Reporting Requirements:
  • Provide regular reports to management on quality performance and metrics to inform decision-making.

Regulatory Compliance:
  • Ensure all activities are performed in accordance with GMP, company SOPs, and health and safety policies to maintain a high level of quality.

Self-Inspection Programmes:
  • Implement self-inspection programs to meet EU GMP/PICS/TG/MHRA requirements to ensure compliance.

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