Alphonse Maria A Email & Phone Number

Bengaluru, Karnataka, India

• Assisted in Internal and External audits to meet regulatory requirements.• Ensured timely closure of QMS documents, including deviations, CAPAs, and change controls, while tracking progress.• Initiated and conducted root cause analysis for deviations, Out of Specification (OOS), and Out of Trend (OOT) occurrences.• Executed Instrument Qualification in alignment with Regulatory requirements (Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).• Prepared and validated Analytical Method Transfer protocols, conducting gap assessments as necessary.• Managed the preparation, modification, review, and approval of worksheets, tests, and test plans within Laboratory Information Management Systems (LIMS) for both current and upcoming projects.• Reviewed and revised Standard Operating Procedures (SOPs) and Standard Test Procedures (STPs) in accordance with verification protocols, method transfer protocols, and analytical test procedures, ensuring compliance with Quality Standards.• Executed method development and transfer activities, along with sample analysis and post-method transfer assessments.• Conducted cell-based assays, Biochemical assays (ELISA's), Molecular Biology testing (HcDNA), and Flow cytometer analyses for batch release.• Ensured the timely release of Quality Control (QC) samples, meeting compliance standards and targets.

Bangalore

• Developed and refined Standard Operating Procedures (SOPs) to enhance clarity and alignment with company standards.• Utilized a variety of problem-solving tools including DMAIC, Flow charts, Pareto Charts, Cause and Effect diagrams, Histograms, Scattered Diagrams, Control Charts, 5 why analysis, and Failure Mode and Effects Analysis (FMEA) to identify and analyze issues. This contributed to a notable 30% decrease in process deviations.• Generated technical reports and documentation such as deviation reports, testing protocols, and trend analysis reports.• Maintained product quality and upheld company standards and procedures by addressing Non-Conformances Material Reports (NCMRs), Corrective And Preventive Actions (CAPAs), and Process Deviations resulting in a significant 20% reduction in non-conforming material.• Analyzed quality and performance data to inform operational decisions. This led to a noteworthy 25% enhancement in product quality. • Monitored Key Performance Indicators (KPIs) to proactively identify and address bottlenecks and quality issues. • Acted as a Subject Matter Expert in Test Method Validation (TMV) for new products. • Participated in both internal and external assessments and audits, including MDSAP, USFDA, and CDSCO audits as per compliance with regulatory requirements such as ISO 13485 and 21 CFR Part 820.• Tested raw materials and finished products to verify quality to ensure compliance with safety requirements.• Executed Method transfer activity, ensuring accurate and reliable testing procedures. Contributed to seamless transition of methods and consistency in testing results.

Bengaluru, Karnataka, India

• Validated equipment and test for Multicolor flow cytometry analysis to ensure accuracy and reliability of results.• Participated in NABL and CAP audit in the year 2015, contributing to successful audit outcomes and continued accreditation.• Maintained Quality Control documents, ensuring accuracy and completeness of documentation. • Conducted workshop during “Hematocon 2015” in Triesta Reference Laboratory, HCG hospital, educating staff on quality control practices.• Performed routine Haematological tests and maintained Quality documents, ensuring accuracy and completeness of records. Resulted in efficient record-keeping and compliance with regulatory standards.• Conducted tests for Acute and Chronic Lymphocytic Leukemia and Hematopoietic progenitor cell antigen (CD34) by Flow cytometer, providing accurate diagnosis and treatment recommendations.

Bangalore

• Analyzed and reported HLA-B27 and CD4/CD8 markers and other Haematological assays, providing accurate diagnostic information to healthcare professionals. • Participated in the validation of Flow cytometer tests, ensuring accuracy and reliability of testing procedures. • Communicated test results to physicians and other healthcare professionals, facilitating timely treatment decisions and patient care.

Bangalore, India

• Coordinated with the Quality Control Manager for External Quality Assurance Scheme (EQAS).• Led the team during NABL audit conducted in 2014, ensuring adherence to regulatory standards and successful audit outcomes. • Validated equipment and tests, ensuring reliability and accuracy of testing procedures. • Maintained Quality Control documents, ensuring accuracy and completeness of documentation.• Tested and analyzed molecular diagnostic assays for various infectious diseases through DNA/RNA extraction and Real-Time PCR. • Conducted testing and analysis of various hormonal levels, infectious and non-infectious diseases, and certain autoimmune diseases by ELISA method.• Performed Enzyme Linked Fluorescent Assay for infectious diseases and tumor markers.• Analyzed and reported HLA-B27 and NK cells by Flow cytometer.