Nikhil Saju Email & Phone Number

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.

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.

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