Quality Assurance - Officer / Executive

Roles & Responsibilities:
• Oversee quality assurance activities across API and pharmaceutical manufacturing
• Conduct audits, inspections, and documentation reviews as per cGMP standards
• Handle deviations, CAPA, change control, and risk management activities
• Ensure compliance with regulatory guidelines (US FDA, WHO, CDSCO, etc.)
• Coordinate with Production, QC, and cross-functional teams for quality improvements
• Prepare, review, and maintain SOPs, BMRs, and validation documents
• Support regulatory inspections, audits, and submissions
• For Managerial roles: Lead QA teams, mentor staff, and drive continuous improvement initiatives

Qualification:
• B.Pharm / M.Pharm /M.Sc (Chemistry, Microbiology, or relevant discipline)

Experience:
• Officer / Executive: 3–8 years in QA (Pharma / API)
• Manager / Sr. Manager: 10+ years including team handling experience

Skills:
• Strong knowledge of cGMP, GLP, and quality management systems
• Experience in deviation management, CAPA, and change control
• Exposure to regulatory audits (US FDA / EDQM / WHO preferred)
• Excellent documentation, communication, and coordination skills

About the Organization:
Arch Pharmalabs is a reputed API manufacturer with globally compliant facilities, offering strong career growth and exposure to international regulatory standards.