Quality Specialist (QMS, Documentation)

Job Description:

Responsibilities

• 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 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.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.

Qualification & Expeirnece

• Exp: 7 Years to 9 Years
• Education: Master degree in Life Sciences, Chemistry, Engineering, or a related field.
• Minimum of 7 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, ANAB) and quality standards (e.g., ISO, GMP).
• Excellent analytical, problem-solving, and communication skills.
• Ability to work collaboratively in a fast-paced, team-oriented environment.