Senior Director of Quality Assurance and Compliance

5 days ago

Solapur, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000
Head of Quality Assurance

Job Description:

As a key member of our quality management team, you will be responsible for ensuring the company maintains a state of readiness for inspection by regulatory agencies. This includes developing and implementing quality audit processes, maintaining GMP quality systems, and establishing a robust Quality Management System (QMS).

The role involves coordinating and performing all vendor qualification activities, internal audits, and compliance audits. You will also be responsible for CAPA close out, developing and maintaining document control systems, and providing quality guidance to product development projects.

You will work closely with various disciplines, including manufacturing, warehouse, and QC, to ensure that all activities are performed in accordance with GMP, company SOPs, and Health and Safety policies.

The ideal candidate will have experience in quality management, auditing, and compliance, as well as excellent communication and leadership skills. You will be responsible for leading and managing change management programs, data integrity internal audits, and training programs.

Additionally, you will be responsible for ensuring that all validation activities are carried out according to approved protocols and requirements, maintaining and improving departmental operational performance, and ensuring regulatory compliance.

The successful candidate will have strong knowledge of cGMP requirements, ICH Q8-Q10, and EU GMP/PICS/TG/MHRA guidelines. They will also have experience in preparing, reviewing, and finalizing documents for external customers and agencies, as well as controlling sample management and stability management.

Required Skills and Qualifications:
  • Experience in quality management, auditing, and compliance
  • Excellent communication and leadership skills
  • Ability to lead and manage change management programs, data integrity internal audits, and training programs
  • Strong knowledge of cGMP requirements, ICH Q8-Q10, and EU GMP/PICS/TG/MHRA guidelines
  • Ability to prepare, review, and finalize documents for external customers and agencies
Benefits:

Others:

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