Senior Manager Quality Assurance

Role Summary This role is responsible for supervising and ensuring quality management system & GMP activities as per applicable CGMP and regulatory requirements, including infernal audits, change control, Deviation & failure investigation, product complaints, quality risk management and CAPA..

Role Responsibilities

• To ensure Quality Management System (QMS) & Good Manufacturing Practices (GMP) compliance and other related policies, guidelines and requirements as applicable by regulatory requirement and company policies.
• To authorize and define the procedures for the basic elements of Quality Management Systems in alignment with the applicable regulatory and cGMP requirements covering WHO, PICs, FDA, ICH, DRAP etc.
• Monitor the reported deviations, failures, complaints and any other anomaly related to product and system failures and identify appropriate CAPA, its effectiveness checks and ensure completion on time.
• Ensure the reliability and consistency of production by checking processes and final output.
• Plan and coordinate for quality management system meetings, minute taking and action follow up covering CC, QRM, CAPA, Complaint, Deviation and Internal auditor meetings.

Relevant Experience 7-10 years of experience in Quality Assurance (Quality Management System & Good Manufacturing Practices)

Education

Skills Competencies