Gokulakrishnan Kumar Email & Phone Number

- Collaborated closely with the Regulatory Affairs (RA) Manager and Deputy RA Manager to ensure equitable distribution of tasks within the regulatory team.- Maintained meticulous records and handled routine paperwork with precision.- Reviewed existing procedures, identifying and addressing areas for improvement.- Managed the regulatory inbox, promptly responding to internal and external queries.- Conducted route validation and risk assessments to mitigate temperature and… Show more - Collaborated closely with the Regulatory Affairs (RA) Manager and Deputy RA Manager to ensure equitable distribution of tasks within the regulatory team.- Maintained meticulous records and handled routine paperwork with precision.- Reviewed existing procedures, identifying and addressing areas for improvement.- Managed the regulatory inbox, promptly responding to internal and external queries.- Conducted route validation and risk assessments to mitigate temperature and security risks effectively.- Conducted qualification checks for customers and suppliers, ensuring annual requalification.- Verified customers and suppliers with the relevant National Competent Authority (NCA) as needed.- Initiated applications for Certificates of Origin (COO) upon request.- Submitted applications for controlled drugs or precursor permits when required.- Reviewed and assessed route validation exercises on the electronic Quality Management System (eQMS).- Managed potentially high-risk or unusual transactions efficiently.- Conducted annual mock recalls and documented recall issues thoroughly on eQMS for each announcement.- Evaluated outcomes of internal audits and addressed concerns promptly on eQMS as necessary.- Investigated complaints, deviations, and tracked trends for communication to the Deputy RA Manager. Show less

Irbīl, Iraq

• Assisted QA departments, Distribution and Supply Chain, and Manufacturing operations teams with quality-related matters.• Managed electronic and paper-based document systems, ensuring compliance and accuracy.• Coordinated onboarding and offboarding of personnel, providing document management training to new hires.• Oversaw compliance with SOP reading, deviation management, and change management processes.• Collaborated in the improvement of document management procedures… Show more • Assisted QA departments, Distribution and Supply Chain, and Manufacturing operations teams with quality-related matters.• Managed electronic and paper-based document systems, ensuring compliance and accuracy.• Coordinated onboarding and offboarding of personnel, providing document management training to new hires.• Oversaw compliance with SOP reading, deviation management, and change management processes.• Collaborated in the improvement of document management procedures, contributing to increased efficiency.• Managed registers and logs, ensuring accurate records for auditing purposes.• Assisted in vendor qualifications and monitored their performance to uphold quality standards.• Led with cross-functional departments to address and resolve quality issues, fostering effective communication and problem-solving.• Served as a QA representative for root cause analysis activities, contributing to continuous improvement initiatives.• Conducted internal audits, promoting a culture of quality and identifying areas for enhancement.• Conducted in-process checks and guaranteed compliance with cGMP regulations.• Performed in Root Cause Analysis (RCA) and contributed to corrective actions.• Collaborated with quality control activities, including batch record review and documentation.• Managed documents within the Quality Management System, including document profiles and collaboration for SOP revisions. Show less

Irbīl, Iraq

Bachelor Of Pharmacy - Bpharm, Pharmacy, Pharmaceutical Sciences, And Administration, Distinction

Education record