Athul Jayasree Anil Email & Phone Number

Dublin, Ie

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 verification, media preparation and equipment preparation● 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.● Filter integrity testing.● Supported validation activities for CIP and SIP of bioreactors and bulk tanks.● Experienced in using automated and process systems (PCS7, PLC,HMI, SAP and MES) and electronic batch records (PAS-X).● Trained in all processes of the Aseptic filling department including working in a grade A environment.

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.● Completes appropriate manufacturing documentation (e.g. BMR), including Inspection records.● Demonstrated proficiency in performing tasks within a cleanroom, including gowning procedures, aseptic techniques, and maintaining cleanroom integrity.● Diligently adhered to quality assurance protocols to meet regulatory standards, including ISO requirements and Good Manufacturing Practices (GMP).● Troubleshoot basic manufacturing equipment.

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.• Cultivated a safety-oriented culture and facilitated daily review meetings, fostering collaboration and enhancing team performance.• Provided support for inspection readiness and reviewed documentation for non-routine work, ensuring thoroughness and accuracy.

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.• Initiated CAPA processes, maintaining compliance with contractual obligations, GVP and Regulatory standards.• Supported Quality functions and accountability of multiple manufacturing sites by reporting PQC for investigations.• Handled logistics of suspect products and replacement products while ensuring compliance with Good Distribution Practices (GDP).• Effectively communicated and collaborated with global pharmacies for replacement products and issuance of credit letters.• Drafted acknowledgement letters and investigation reports for effective communication with reporters.• Supported product recall activities by helping identify recalled products and instructing temporary quarantine procedures.• Ensured adherence to SDEA requirements and contract requirements between clients and other stakeholders. • Ad hoc tasks such as Quality checking (QC) cases and reports, project mailbox management, task delegation and training new joiners.• Contributed to the overall improvement of the quality of the deliverables by continuous improvement in the process.

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