Quality Assurance Officer

About Mangalam Drugs & Organics Limited

Established in 1977 at Vapi, Gujarat, Mangalam Drugs & Organics Limited specializes in manufacturing Active Pharmaceutical Ingredients (APIs) and their intermediates. With two production sites and a recognized in-house Research & Development laboratory, Mangalam has earned a global reputation as a key supplier of frontline Anti-Malaria APIs. The company also offers a diverse product lineup benefiting from operational synergies and economies of scale, positioning it among Asia's leading manufacturers and the largest producer worldwide for certain products.

Job Responsibilities

• Conduct in-process quality checks throughout API production to ensure compliance with current Good Manufacturing Practices (cGMP) and established Standard Operating Procedures (SOPs).
• Observe and monitor critical process parameters, documenting findings accurately.
• Carry out verification of line clearance, equipment condition, and overall cleanliness to maintain quality standards.
• Report any deviations promptly and assist in related investigations and Corrective and Preventive Actions (CAPA).
• Collaborate effectively with Production, Quality Control (QC), and Quality Assurance (QA) departments.
• Review Batch Manufacturing Records (BMR) thoroughly to confirm accuracy, completeness, and conformity with approved protocols and regulatory guidelines.
• Ensure documentation aligns with ALCOA+ principles to uphold data integrity.
• Identify and address discrepancies in records, facilitating their timely resolution.
• Support audit processes and regulatory inspections by maintaining high-quality documentation standards.
• Oversee dispatch-related paperwork including Certificates of Analysis (COA), packing lists, invoices, and labels, ensuring all QA releases API batches before shipment.
• Confirm compliance with customer specifications and regulatory mandates during dispatch procedures.
• Maintain communication across Warehouse, QC, and Logistics teams to guarantee smooth coordination and traceability of shipments.
• Prepare and review Environment & Safety (E&S) documentation to assure adherence to legal and regulatory safety standards.
• Manage SOPs, risk evaluations, and safety records associated with EHS compliance.
• Assist in audit preparation and inspections related to environmental health and safety policies.
• Coordinate document control efforts with EHS and QA teams to maintain up-to-date and accurate records.