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.

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.
• 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.
• 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.

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.