Merck KGaA
Manager Quality Assurance
Job Description
Job Title: Quality Assurance ManagerLocation: Jigani,Bangalore Role descriptionThe Quality Assurance (QA) Manager will oversee the quality assurance processes within the Life Science division in India. This role is critical in ensuring that all products and processes meet the required quality standards and comply with regulatory requirements.Develop, implement, and maintain the quality management system (QMS) in accordance with regulatory requirements and industry standards.Lead and manage quality assurance activities, including audits, inspections, and investigations.Collaborate with cross-functional teams to ensure product quality throughout the product lifecycle.Monitor and analyze quality metrics to identify trends and areas for improvement.Prepare and review quality documentation, including standard operating procedures (SOPs), validation protocols, and reports.Provide training and guidance to staff on quality assurance practices and regulatory compliance.Facilitate communication with regulatory agencies and ensure timely responses to inquiries and inspections.Drive continuous improvement initiatives to enhance product quality and operational efficiency.Job Requirements Master degree in Life Sciences, Chemistry, Engineering, or a related field.Minimum of 10 years of experience in quality assurance within the pharmaceutical/ Chemical/life sciences or biotechnology industry.Strong understanding of regulatory requirements (e.g., FDA, EMA, NABL ) and quality standards (e.g., ISO, GMP).Proven leadership and project management skills.Excellent analytical, problem-solving, and communication skills.Ability to work collaboratively in a fast-paced, team-oriented environment.
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