Quality Control and Quality Assurance

Roles & Responsibilities

Quality Control (QC)
• Perform analytical testing using HPLC, GC, and wet chemical analysis to ensure product quality
• Analyze raw materials, intermediates, and finished products as per quality standards
• Prepare SOPs in compliance with regulatory requirements including stability studies and market sample analysis
• Maintain GLP-compliant documentation and accurate records for audit and regulatory compliance
• Operate laboratory software systems for analytical testing, reporting, and data management

Quality Assurance (QA)
• Ensure cGMP and regulatory compliance across QA operations
• Manage AQA, IPQA, batch release, deviation handling, CAPA, change control, and audit activities
• Review analytical data and ensure adherence to data integrity principles (ALCOA+)
• Monitor shop-floor QA activities, in-process checks, and documentation compliance
• Oversee equipment qualification, preventive maintenance, and calibration reviews
• Prepare quality documentation as per regulatory and organizational requirements
• Support automation, digitalization, and continuous quality improvement initiatives

Qualification
• M.Sc Organic / Analytical Chemistry or M.Pharm

Experience
• QC: 2–5 years of experience in API industry
• QA: 3–8 years of experience in API industry

Skills
• Strong knowledge of cGMP, GLP, and regulatory compliance requirements
• Hands-on experience with analytical instruments such as HPLC and GC (for QC role)
• Experience in deviation management, CAPA, and quality systems (for QA role)
• Understanding of data integrity principles (ALCOA+)
• Good documentation, analytical, and problem-solving skills
• Ability to work in cross-functional manufacturing and quality environments

Walk-In Details
• Date: 07 February 2026 (Saturday)
• Time: 09:30 AM to 03:00 PM
• Venue: 2nd Floor, Prestige Plaza, Urmi Society, Opp. Toprani Lab, Akota, Vadodara
• Candidates unable to attend may share CV at: careers@amilifesciences.com

About the Organization
Ami Lifesciences Pvt. Ltd. is a fast-growing pharmaceutical company specializing in the development and manufacturing of active pharmaceutical ingredients (APIs). Known for strong regulatory compliance and innovation-driven processes, the organization serves global pharmaceutical markets with high-quality manufacturing standards.