Athul Jayasree Anil Email & Phone Number

Dublin, County Dublin, Ireland

• Part of the Albumin purification team for commercial facility startup.
• Responsible for executing purification process of Albumin.
• Ensuring that the gowning philosophies for all cleanroom, production and facility areas.
• Carried out suspension, clarification, ultra-filtration, diafiltration, formulation, buffer makeup, heat shock/pasteurization, sterile filtration, pH adjustment, in process sampling, CIP, SIP, manual cleaning, cleaning.
• Performed daily standardization and calibration of analytical equipment’s used for processes, including pH and conductivity meter, UV-Vis Spectrophotometer, Turbidimeter, Refractometer and Osmometer.
• Weighing out raw materials, chemicals for stabilizer make-up, buffer make-up.

Roscommon, County Roscommon, Ireland

• Completes all production activities, per documented procedures, related to the manufacturing of Intra Ocular Lens (IOLs) or associated products.
• Monitor relevant documentation of products in accordance with ISO 13485, ISO 14971 and FDA 21CFR Part 820.
• Skilled in microscope operation for detailed inspections and quality assessments of intraocular lenses.
• Work in accordance with SAP MES systems for documentation process and packaging of products.
• Demonstrates proficiency using Trioptics for precise measurement of Diopter power, Modular Transfer Function (MTF), and aperture offset in hydrophobic intraocular lenses, ensuring accurate optical assessments.
• Expertly handles the hydration process for both hydrophilic and hydrophobic intraocular lenses, adhering to quality standards and ensuring meticulous lens preparation.

Chennai, Tamil Nadu, India

• Ensured strict adherence to Standard Operating Procedures (SOPs) and regulatory requirements in processing pharmaceutical safety data, prioritizing data integrity.
• Collaborated with cross-functional teams to enhance quality and regulatory compliance through active participation in meetings and discussions.
• Conducted thorough troubleshooting and root cause analysis (RCA) for operational deviations, implementing effective Corrective and Preventive Actions (CAPA) to drive continuous improvement.
• Developed and executed comprehensive quality management plans, resulting in notable enhancements in quality and regulatory compliance.
• Managed internal and external audit processes, maintaining a high compliance rate and a reliable Quality Management System (QMS).
• Demonstrated expertise in maintaining robust QMS, ensuring adherence to industry standards and SOPs with a consistent focus on achieving compliance.

Kochi, Kerala, India

• Assisted an international Post Market Surveillance (PMS) project to ensure the quality compliance of medical products.
• Responsible for acknowledging and comprehensive intake of customer Product Quality Complaints (PQC), reporting Adverse Events (AE), and responding to technical queries.
• Operating QMS, reviewing and approval of QMS records such as Spontaneous PMS cases (Complaint Handling & AE Reporting), Deviation reports, Root Cause Analysis (RCA), CAPAs and Risk analysis.
• Complaint handling by logging AE and PQC cases in QMS, generating source documents for ICSRs, controlling these documents' distribution with cross-functional teams, and providing end-to-end service for each complaint.
• Monitored QMS records of spontaneous case reports, analysed case metadata and audit trails on IRMS to ensure compliance
• Reviewed documents and identified process deviation instances, conducted RCA for investigation.

Pathanamthitta, Kerala, India

Msc Pharmaceutical Business And Technology, Pharmaceutical Sciences

Medical Insurance Coding Specialist/Coder

Bachelor Of Pharmacy - Bpharm, Pharmaceutical Sciences, 67%

Bachelor Of Pharmacy - Bpharm