ALI ADEN SHIRE

Tel:+254-***-***-*** Email:ad3z6a@r.postjobfree.com

P.O BOX 88679, 80100 Mombasa, Kenya

Medical Microbiologist Clinical Research Scientist Laboratory Quality Assurance Specialist

(GCLP) Laboratory Analyst

PERSONAL PROFILE

● I am a microbiologist and laboratory technologist with experience in clinical trial research of over 5 years. professional with over 2 years of hands- on experience in a Biosafety Level 3 (BSL3) laboratory setting. Proven expertise in senior roles, demonstrating a strong command of modern methodologies for detecting, isolating, and characterizing Mycobacterium tuberculosis (M.tb).

● A motivated and seasoned professional in Laboratory Quality Management, possessing a robust track record in upholding top-tier standards of quality and precision in laboratory operations. Proficient in implementing and sustaining quality management systems following Good Clinical Laboratory Practices (GCLP) guidelines to align with regulatory mandates and enhance operational efficiency. Experienced in team leadership, conducting audits, and adept at crafting comprehensive Standard Operating Procedures (SOPs) and Risk Assessments. Demonstrates effective communication skills in collaborating with cross-functional teams and engaging stakeholders. CORE COMPETENCIES

Research and analysis Finding research articles and publications on a wide range of scientific research topics

Develop monitor and implement Quality assurance and Quality Management System (QMS)

Laboratory Internal Auditing. In preparation for the ISO 15189-2012.

Knowledgeable in DAIDS GCLP guidelines and the knowledge to implement them.

Training laboratory personnel in providing quality clinical trials.

Laboratory Standardizations (reference system, traceability procedures, and verification procedures)

Performing audits in according with the GCLP guidelines

Shipping samples according to the IATA guidelines

Laboratory Equipment and Operation.

Laboratory Safety Protocols (BSL3)

Mycobacterium tuberculosis Detection and Characterization

Mycobacteria Growth Indicator Tube (MGIT) Culture

Strategic Mindset in planning. Projection and execution of projects.

A thorough understanding of general laboratory equipment and its operating principles,

Good interpersonal and skilled in writing technical reports and ensuring the technical quality of technical outputs

Working Knowledge of GXP

WORK EXPERIENCE

PPD part of Thermofisher Quality Assurance GCLP Auditor I April 2023 – 31 July 2023

Performed routine GCLP audits. Work assignments include multiple therapeutic indications across different projects and clients.

Conducted a variety of client, internal, or GxP audits and supported regulatory inspections as requested by senior management

Participates in process audits.

Performed other types of QA audits or activities (e.g., database audits, clinical study report audits, sample results tables, facility audits, process improvement)

Served as a resource to operational departments on audit or quality assurance subject matter.

Prepares and presents audit findings and/or other related information at departmental, internal operations, or client meetings. INTERNATIONAL CANCER INSTITUTE Mar 2022- March 2023 Laboratory Manager

General Administrative Responsibilities

Fulfilled the functions of the general supervisor for regulatory requirements and registration and accreditation of the ICI laboratories with the relevant bodies including KENAS and RCPA, UK NEQAS, and HUQAS in compliance with the ISO15189-2012 standards.

Registration and/or accreditation of the ICI lab's Bio-banking program with the relevant local, regional, and international bodies and in compliance with the ISO15189-2012 standards.

Developed and maintained Standard Operating Procedures (SOPs) according to the internationally recommended standard guidelines - Responsible for developing and implementing SOPs necessary to attain and maintain regulatory certification.

Ensured that policies, SOPs, and protocols were harmonized with relevant rules, regulations, quality standards, and good clinical practices in accordance with ISO15189-2012 and GCLP guidelines.

Prepared and carried out laboratory and research internal audits and departmental inspections to ensure continuous improvement quality management system.

Actively participated in Quality Improvement Programs essential in ensuring that laboratory testing is accurate, and consolidating meetings with the management following the GCLP guidelines and ISO 15189-2012

Responsible for core laboratory equipment liaising with company representatives concerning maintenance and repairs negotiating the best possible deal for service and/or repair costs.

Trained all staff members and other personnel in basic laboratory skills, health and safety practices, in operating some core laboratory equipment.

Monitoring and ordering of research materials/consumables and equipment, as well as recharging the research groups appropriately.

Maximized resources within budget constraints, negotiating discounts with suppliers and contractors and ensuring equipment and consumable procurement procedures were provided.

Initiating purchase orders for repairs, service contracts, goods, etc. working closely with the finance and logistics team.

Maintained and organized financial records for recharges, contracts, breakdown/repair visits,

Maintained an electronic online-based register and records of equipment (including servicing and repairs) and training, as well as alarm monitoring systems for cold storage and cryogenic storage.

Ensured good maintenance of laboratory support and provided for other support and/or technical staff as necessary.

The Laboratory Quality Assurance Responsibility.

Developing and implementing processes, procedures, and guidelines that comply with industry standards and regulations. Designed to ensure that all aspects of the organization's operations are carried out in a controlled and standardized manner.

Documentation Management, Creating, reviewing, revising, and maintaining all QMS-related documentation, such as quality manuals, standard operating procedures (SOPs), work instructions, forms, and templates. Ensuring that these documents are accurate, up-to-date, and easily accessible to relevant personnel.

Managing various QMS events, including audits, inspections, reviews, and corrective/preventive actions. This involves planning and scheduling these events, coordinating with relevant stakeholders, and ensuring that the necessary documentation is prepared and maintained.

Providing training to employees on QMS processes and procedures, ensuring that they understand their roles in maintaining quality standards. Facilitating communication between different departments to promote a culture of quality and continuous improvement.

Monitoring the effectiveness of the QMS and identifying areas for improvement. This may involve conducting root cause analyses, trend analysis, and data-driven decision-making to address any recurring issues and enhance overall quality.

Compliance and Auditing: Ensuring that the organization remains compliant with applicable regulations, standards, and customer requirements. Conducting internal audits to assess the organization's adherence to QMS processes and identifying opportunities for improvement.

Risk Management:-Identifying potential risks to quality and implementing strategies to mitigate them. This could involve evaluating supplier quality, assessing process vulnerabilities, and implementing contingency plans.

Measurement and Analysis: Establishing key performance indicators (KPIs) and metrics to monitor the performance of the QMS and track improvements over time. Analyzing data to make informed decisions and drive continuous improvement efforts.

Regulatory Compliance: Staying up-to-date with relevant industry regulations, standards, and guidelines, and ensuring that the QMS remains aligned with these requirements.

Research Responsibilities

Laboratory Clinical Trials Coordinator.

Overseeing operations of the ICI Biobank and promoting coordination with other departments including Research, ICI Laboratories, and the Division of Clinical Care.

Collect tissue samples and process them for different research applications.

Analyzing patient tissue to determine the presence of a pre-existing or neoplastic genetic condition.

Dispatch laboratory results to study participants for further information on diagnosis.

Liaise with principal investigators and physicians to optimize the bio-banking of tissues.

Assist with data generation and collation of biobank information.

Liaise with the CRA ensuring the laboratory is up to standards following the protocol and manual required.

Writing research papers, reports, reviews, and summaries (reviewing research ethics board applications and amending accordingly). Education & Training Responsibilities

Coordinating and conducting education and training programs for personnel.

Developing training/competency checklists and providing clinical orientation and/or training of new employees/students.

Supporting Education & Training Department personnel in the training through the development of training curricula and facilitation of training programs.

Actively participating in the continuous system improvement and continuing education programs. Safety Management Responsibilities

To act as the Division Safety Coordinator.

To be responsible for health and safety-related incidents within the laboratories and office areas.

To advise principal investigators, staff, and other personnel on day-to-day operational safety and compliance with ICI and statutory safety requirements.

To advise on the appropriate arrangements for managing and monitoring Health and Safety during safety meetings.

To produce and keep/maintain up-to-date relevant safety documents such as safety protocols, training records, MSDS, and safety incident reports.

To control the waste management system to ensure safe disposal of waste, including biological, and chemical waste, etc.

To carry out health and safety inspections and to assist in safety audits, and where relevant disseminate the relevant information and reports to the appropriate persons.

Marketing Responsibilities

Accountable for meeting long-term (3-5 years) and short-term (90-day) goals, priorities, and strategic outcomes within the core lab marketing plans.

Responsible for the day-to-day alignment, enablement, and oversight of other marketing teams.

Serving as a member of the Marketing Leadership Team that represents lab systems, automation, IT, reagents, and customer marketing.

Analyzing and assessing existing market gaps to extrapolate meaning and opportunities that drive overall market strength and positioning in existing and potential areas.

Ensuring high-quality tactical execution and a seamless, well-integrated brand message and overall position across multiple marketing platforms.

Creating and driving strong linkage to partners and clients to ensure achievement of objectives with successful stakeholder engagement for development and maintaining of strong relationships with key clients and other external individuals/organizations.

Development of effective promotional tactics and effective pull-through of this tactic. Key Achievements

1. Successfully reduced histology Turnaround Time (TAT) from 10 working days to 5 working days, enhancing efficiency. 2. Introduced new assays in the laboratory reducing the number of tests being referred. 3. Elevated laboratory quality systems, ensuring readiness for clinical trials. 4. Led the laboratory clinical trials team, overseeing the management of 7 clinical trials. 5. Implemented Good Documentation Practices and conducted staff training to maintain study-related documents effectively. 6. Pioneered a strategic projection plan for laboratory supplies and study kits, streamlining resource management. 7. Enhanced safety protocols in the laboratory, including improvements in procedures for handling dry ice. KEMRI /CRDR (Center for Respiratory Disease Research) January 2019 to March 2022 Lead Laboratory Analyst/Quality Assurance

I have been involved in 6 key clinical trial projects on malaria, tuberculosis, and sickle cell disease. These studies were phases II and III and included both drug and vaccine trials. My contributions to these research projects have revolved around:

Strengthening TB diagnostics involves assessing the current situation, engaging stakeholders, building capacity improving laboratory infrastructure, implementing quality management systems, exploring point-of-care testing, engaging communities, fostering research and innovation, adhering to global standards, and pursuing continuous improvement. In clinical trials.

I maintained a working knowledge of the ICH/GCP Guidelines, GCLP Guidelines, and ISO 9001-2015.

Carrying out real-time QA/QC procedures on lab documents, participant files, the laboratory section of the investigator site file, and staff training logs.

Prepare and carry out laboratory research procedures and departmental inspections to ensure continuous improvement in quality management systems.

Ensure that the laboratory has the necessary infrastructure, equipment, and supplies to conduct proper diagnostics efficiently. Implemented maintenance schedules for equipment and established a regular supply chain for consumables.

Implemented a QMS based on GCLP guidelines to ensure the quality and accuracy of diagnostic services. Train laboratory staff on QMS and conduct regular internal and external quality assessments.

Write and revise Standard Operating Procedures (SOPs) and Risk Assessments to enhance laboratory efficiency and safety.

Established and strengthened networks among healthcare facilities and laboratories to ensure efficient specimen referral and result sharing. Developed clear protocols and communication channels for referral and feedback.

Implemented robust data management systems to track patient information, diagnostic results, and treatment outcomes. This was crucial in monitoring and evaluating the patient’s well-being.

Developed a sustainability plan that includes training laboratory personnel to improve the laboratory QMS, and targeting the key quality indicators that are set.

Establish a culture of continuous improvement where feedback from all stakeholders is valued and used to refine the laboratory systems.

Creating and controlling system documentation like sample tracking logs, sample chain of command documents, and sample transportation tracking logs. Enabling easy tracking and identification.

Training new employees and performing continuous refresher training on SOPs, QMS, and LIS.

Carrying out real-time QA/QC procedures on lab documents, participant files, the laboratory section of the investigator site file, and staff training logs.

Perform semi-annual comparison testing, QC functions, calibration testing, and software updates on the biochemistry analyzer, Hemoque +201 Beckman Coulter CBC, and ensure equipment service is up to date.

Maintain equipment, laboratory kit, and supplies inventory.

Monitor and record temperature readings in the Laboratory and document any excursion done through CAPA. Personnel safety

Chemical Handling and Storage:

Implemented proper storage protocols for chemicals, ensuring compatibility and segregation. Provided adequate ventilation and used fume hoods handling hazardous substances.

Emergency Procedures:

Communicated emergency procedures, including evacuation routes and assembly points. Conducted regular drills to ensure everyone was familiar with emergency protocols.

Safety Training:

Conducted comprehensive safety training for all personnel, including new hires and visitors. Ensured ongoing education on safety protocols and procedures.

Communication:

Established clear lines of communication for reporting safety concerns or incidents. Encouraged open dialogue regarding safety and created none-punitive action.

Key Achievements

Laboratory Startup Preparation: Successfully prepared the laboratory for various study startups, ensuring all necessary resources and equipment were in place to initiate research projects effectively.

Audit Readiness: Examined laboratory documents and procedures to ensure they were audit-ready, demonstrating a commitment to compliance and quality assurance.

Stakeholder Relationship Building: Developed a strong rapport with the Siaya County Referral Hospital, facilitating timely blood sample collection for research participants, efficient COVID testing, and timely result reporting. Additionally, gained valuable exposure to their equipment and received training on their operation.

SOP Development: Took the initiative to create and implement new Standard Operating Procedures (SOPs) for the site, including CAPA (Corrective and Preventive Actions) SOP, Contingency Plan for the -80 C freezer, Management Review SOP, and Quality Improvement SOP, enhancing laboratory operations and quality control.

Pediatric Sample Collection: Completed the collection of samples from pediatric participants, showcasing your ability to handle sensitive and challenging tasks in a research setting.

Audit Support: Conducted various client, internal, or GxP (Good Practices) audits and provided valuable support during regulatory inspections as requested by senior management, contributing to regulatory compliance and quality standards.

Audit Reporting: Prepared and presented audit findings and related information at departmental, internal operations, or client meetings, effectively communicating audit results and recommendations to relevant stakeholders. WASHINGTON UNIVERSITY COAST GENERAL (GENE-ENVIRONMENT INTERACTIONS IN THE September 2018 – January GENESIS OF SUBSTANCE DEPENDENCE, PSYCHOSIS AND RELAPSE IN KENYA) Laboratory Analyst / Research Project Assistant

● Received vaginal mucosal samples for processing & verification.

● Use of Hologic propriety real-time amplification PCR in targeting virus bacteria and fungi on sexually infected samples and Provided standards to strengthen access and quality of culture-based and molecular diagnosis of bacterial/fungal infections.

● Molecular genetics of various sexually transmitted infections while identifying research gaps and priorities, and supporting operational research activities related to existing tools as well as the introduction of new and innovative diagnostic tools and technologies.

● rational use of quality assured diagnostics for the identification, characterization and resistance determination of infectious pathogens at the different level of the health system in coast general hospital.

● Storage of samples according to freezer works database constantly updating them monthly.

● Explained research requirements and performed informed consent for the clients.

● Created and ensured standard operating procedures are followed in accordance with the project guidelines.

● Collected and transported blood samples to the laboratory for processing and analysis. 2019

Medisel (Kenya) Limited

Quality Assurance Officer Attachment

● Validated and analyzed raw materials to ensure they were within the specific parameters per the pharmacopeia.

● Measured Items to ensure they are in the specified parameters and dimensions.

● Conducted efficacy tests on disinfectants, preservatives and antibiotics.

● Analyzed microbial load limit, cultured and identified isolated different species of microorganisms.

● Enhanced laboratory safety practices, good laboratory and documentation practices.

● Conducted chemical analysis and identified starting materials, intermediate and finished products

● Maintained analytical instruments and equipment. Thika Level 5 Hospital

Laboratory Technologist Attachment

● Identified and diagnosed parasitic organisms in stool, blood, and urine using different microbiological techniques

● Carried out blood work analysis for appropriate diagnosis and treatment of patients.

● Offered guidance and counseling to people living with HIV and AIDS and provided a detailed record for every consultation.

● Provided a clear number of CD4 counts for people living with HIV and AIDS

● Performed over 25 daily Gene-Xpert analyses for suspected and confirmed patients.

● Antibody identification for immunology assessments

● Received patients and made them feel calm and secured

● Kept laboratory results and filled them according to the specific departments. March 2018 - May 2018

July 2017 - September

2017

Pandya Memorial Hospital

Attachment

● Identified and diagnosed various parasites in stool, urine and blood

● Provided blood work analysis to guide and help arrive at a good diagnosis.

● Scanned blood transfusion

● Performed microbiological analysis of infectious diseases.

● Performed serological analysis.

● Provided a clear number of CD4 counts for people living with HIV, AIDS & other autoimmune diseases.

● Performed biochemical tests to assess liver function, renal function and bone(s) May 2014 - July 2014

EDUCATION & PROFESSIONAL DEVELOPMENT

DAIDS Good Clinical Laboratory Practice (GCLP)

RANQUAL Reliable solution to Quality Management System

Risk Assessment ISO-15189-2022

Human Quality Assessment Service (HUQAS)

Completion of the ISO-15189-2022

Completion of internal Quality Audit based on ISO-15189-2022

Method Validation, Verification, and Measurement Uncertainty ISO-15189-2022 Gertrude Children Hospital

● Certificate of Child Phlebotomy

May 2023

April 2023

June- October 2022

Sep - Oct 2020

University of Washington

● Fundamental of global health research

● Introduction to epidemiology

April - Jun 2020

Jan- April 2021

JOHNS HOPKINS UNIVERSITY

● Certificate in Design and Interpretation of clinical trials. Jan - April 2020

GLOBAL HEALTH NETWORK

● Certificate in Clinical Research

● Certificate in Good Laboratory Practice.

● Certificate in basic malaria microscopy

Dec 2018

Nov 2020

Nov 2018 - Jan 2019

JOMO KENYATTA UNIVERSITY OF AGRICULTURAL TECHNOLOGY, JUJA

● Bachelor of Medical Microbiology (Diagnosis)

Second Class Honors lower

Sep 2013 - Nov 2017

SEMINARS & WORKSHOPS

HIV health seminars

o Guiding and counseling people living with HIV and AIDS. o Engaging and educating the community on the disastrous effects of stigmatization. July 2018

Cervical cancer awareness programs around Mombasa town in cooperation with The Coast General Hospital Sep 2018 - Jan 2019

Mombasa youth group seminar on life skills for development April 2018 - Aug 2018 ADDITIONAL

● Languages: English (proficient) & Swahili (proficient) French (Novice)

● Community service

o Cleaning Mombasa beaches with the Mombasa Red Cross Society. o Participated in blood collection for blood donation drives. o Menstrual hygiene advocacy for underprivileged secondary students and orphanages in Mombasa. REFEREES

Dr. Anisa Mburu

Gynecologist AKU

Phone: +254-***-***-**

Email:ad3z6a@r.postjobfree.com

Dr. Irene Mugenya

Research/Medical officer/ Project Manager

KEMRI Welcome Trust: +254-***-***-***

Email: ad3z6a@r.postjobfree.com

Dr. Simon Kariuki

Principal Investigator KEMRI CGHR

Phone: +254-***-***-***

Email: ad3z6a@r.postjobfree.com

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