KARPAGAM MOGAN

R&D Executive Nov 2013 - Jun 2019

-Monitor quality, stability and safety of products throughout the shelf life

DQA Executive Jun 2019 - Apr 2024

-Review standard operating procedures, monitor testing procedures to meet established specifications, standard test methods or pharmacopeia monograph

-Strengthened internal controls by conducting regular reviews and updating standard operating procedures as needed, promoting consistency in compliance practices across all departments.

- Assisted with internal and external audits to confirm compliance with ISO 9001: 2015 and MS ISO/IEC 17025 : 2017.

- Maintain up-to-date documentation of compliance procedures, including records of inspections, audits, and corrective actions

-Implemented effective compliance policies and procedures to meet regulatory requirements.

Compliance Executive in May 2024 - Present

- Lead and mentor the IPQC team, providing guidance, support, and training to ensure effective performance

- Drive continuous improvement in in-process quality control procedures to enhance product quality and operational efficiency.

- Regularly review and update IPQC procedures and policies to reflect changes in regulations, industry standards, and company practices.

• Had exposure to lab procedures in several departments which include Haematology, Biochemistry, Immunology and Microbiology with hand on experience
• Review analytical reports and validate the results prior releasing to doctors and patients

• Work well independently and within team in Hospital based environment
• Performed routine and complex laboratory tests, validate and report test results in various lab disciplines such as Biochemistry, Hematology, Blood Banking, Immunology, Serology & urinalysis
• Had been in-Charge of Biochemistry Department responsible for monitoring of daily internal and external quality control, stock monitoring, maintenance with proper documentation