Quality Assurance - Manager / Sr. Manager

Roles & Responsibilities:
• Lead and manage Quality Assurance activities across API and pharmaceutical manufacturing
• Oversee implementation and compliance of cGMP, GLP, and quality management systems
• Review and approve SOPs, BMRs, validation documents, and quality reports
• Drive deviation management, CAPA effectiveness, change control, and risk assessments
• Lead internal audits and support regulatory inspections (US FDA, WHO, CDSCO, EDQM)
• Ensure data integrity, audit readiness, and continuous improvement initiatives
• Coordinate with Production, QC, Regulatory Affairs, and cross-functional teams
• Mentor, train, and develop QA team members; manage workload and performance

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

Experience:
• 10+ years of experience in Quality Assurance (Pharma / API)
• Mandatory team handling and leadership experience

Skills:
• Strong expertise in cGMP, GLP, and global regulatory requirements
• Proven experience in regulatory audits and inspections
• Excellent leadership, decision-making, and stakeholder management skills
• Strong documentation, compliance, and problem-solving abilities

About the Organization:
Arch Pharmalabs is a reputed API manufacturing company with globally compliant facilities, offering leadership roles with strong exposure to international regulatory standards and continuous improvement initiatives.