Nikhil Saju Email & Phone Number

Dublin, Ie

Dunboyne, County Meath, Ireland

Dublin, County Dublin, Ireland

• Assembled diagnostic kits and verified BMRs.• Assisted in maintaining a safety-oriented culture, cGMP, GDP, and complaint work environment at all times, by meeting the requirements of ISO 13485.• Collected and verified sample kits produced (in-process/ finished), inspected incoming raw materials and ensured that are in accordance with applicable procedures, specifications and meet appropriate acceptance criteria.• Communicated with the management on product quality issues immediately and documented on-hold notices and quality alerts efficiently and participated in implementing continuous improvement site projects and initiatives.• Assisted the management in collating and presented the daily and weekly quality metrics.

County Dublin, Ireland

• CORE MODULES: Validation Life Cycle, Clinical Trials Regulation, Waste Management, Analytical Method Transfer, Process Validation, Innovative Medicines, Patient Outcomes, BGIE, Lean Enterprise, Six Sigma & KPI Strategic Thinking in Achieving Technological Innovation, Corporate Governance & Business Ethics, Drug Development Lifecycle, Clinical Research & Trials, Future Trends In Clinical Research,

Saggart,Ireland

Patient Care,Manual Handling

Kozhikode, Kerala, India

• Ensured all phases of manufacturing and other handling process met the standards and requirements of the quality plan including in-process check.• Performed an active role in all stages of the production process (Raw Materials Analyst), during production itself (In Process Analyst) and at the end of manufacture (Finished Product testing).• Completed all experiments on time according to established Standard Operating Practices (SOPs), and Good Laboratory Practices (GLP) and ISO/ EN standards.• Managed minor equipment troubleshooting, calibration and repair and established specifications for conducting assays and standard operating procedures.• Monitored supplier performance/ compliance documents (Audit response/CAPA) and supported the team in taking informed decision on approving the supplier/vendor/service provider.• Developed risk assessment strategies, implemented root cause analysis and validation checks to prevent future issues.• Applied regulatory knowledge to manufacturing operations, utilized QMS principles, managed quality software, and drove process improvements through Lean and Six Sigma methodologies.• Employed Lean and Six Sigma methodologies to drive process improvements, minimize waste, and optimize overall efficiency while providing valuable health and safety insights.

Kanhangad

• Provided safe, efficacious, and accurate dose of drug, depending on each patient needs and their physiological and pathological conditions.• Collaborated with the team to identify and promote high-margin products, contributing to a 25% boost in overall sales revenue.• Conducted thorough examinations of merchandise and consumables while meticulously implementedstreamlined inventory management systems that reduced stock discrepancies by 10%.• Performed warehouse inspections & organized equipment services & repairs, including procuring POnumbers.• Reported issues (raising Investigation Reports) & adhered to Store-All policies and SOPs at all time.

Kasaragod, Kerala, India

Kasaragod, Kerala, India

Master In Pharmaceutical Busines &Technology, Pharmaceutical Marketing And Management

Bachelor Of Pharmacy - Bpharm, Medicinal And Pharmaceutical Chemistry, 70%

High School, Science, 93 %

Master In Pharmaceutical Business &Technology, Pharmaceutical Marketing And Management, Ongoing