Handling QMS as per Regulatory requirements. Handling Deviations, CAPA, Change Controls, OOS investigations. Responsible to process internal quality audits.
Evaluate change control requests and assess their impact on product stability. Review laboratory test results (CoAs), investigate OOS/OOT findings, and prepare non¬conformity reports.
BDR Group of companies has grown steadily and become a house-hold name in the pharmaceutical Industry over the last 15 years, in both domestic and international arenas
Workmen allocation and manpower management on shift basis. Supervision of secondary packing operations, especially bottle lines. Compliance with cGMP, safety, and hygiene requirements.
Seeking a highly experienced Regulatory Affairs professional to manage regulatory activities for parenteral (injectable) products across the LATAM region. The role involves end-to-end regulatory lifecycle management, ensuring timely submissions, approvals, and compliance with regional regulatory requirements.
The ideal candidate must have hands-on experience in ophthalmic formulations, along with strong expertise in autoclave handling and batch manufacturing processes. Knowledge of GMP and quality compliance is essential.