Quality control and quality assurance specialist
Resume:
Province Zambia
**********@*****.***
SUMMARY
Exceptional Chemical and
biological scientist with hands-on
experience in chemistry,
microbiology and instrumentation.
Methodical professional in quality
control management, known for
high productivity and efficient task
completion. Possess specialized
skills in statistical process control,
ISO 9001 standards, ISO 17025
standards and risk management.
Excellent critical thinker, problem-
solver and communication skills
ensuring best operations and
continuous improvement across all
quality systems.
SKILLS
• Goal and quality oriented
• Excellent communication skills
Proficient in excel, word, power
point
•
Analytical method development
and validation
•
• Regulatory compliance
• Root cause analysis (RCA)
• Process improvement
• Internal audits
• Team management
• Employee training
Simoonga Mulunda
EXPERIENCE
October 2018 - Current
Quality Control Head Yash Life Sciences Limited Kafue, ZM November 2017 - October 2018
Quality Control Manager Kingphar Zambia limited Lusaka, ZM Manage a team of Quality Control Technicians responsible for analysis of raw materials, intermediates and finished pharmaceutical products.
•
• Active participant in regulatory inspections and lead internal auditor.
• Approve or reject raw materials and finished products Develop, verify and validate analytical methods as per pharmacopoeial, WHO and other international standards requirements
•
Evaluate analysts technical skills and impart trainings on technical skill improvement
•
Identify process improvements through root cause analysis investigations.
•
Develop and implement quality control processes to ensure product compliance with industry standards.
•
Plan and ensure that all Laboratory requirements for sample analysis are available, properly utilised and manage consumption records
•
Review of critical documents such as cleaning validation protocols, instruments qualifications, Quality Risk Management Reports
•
Ensure that adequate manpower is in place for smooth operations of the laboratory.
•
Create detailed reports on the performance of quality control measures and present findings to senior management.
•
Train personnel on proper analytical techniques and methods used in quality control.
•
Investigate customer complaints regarding product issues, analyze data, provide recommendations for resolution.
•
Provide technical expertise regarding product design, changes or modifications.
•
Oversee the development of new products, ensuring that all design requirements are met prior to production.
•
Conduct routine maintenance and repairs on sophisticated analytical instruments.
•
Utilize advanced technical skills and expertise to troubleshoot complex problems and implement solutions.
•
• Prepared all initial SOPs for quality control department. Qualified all instruments in quality control and valifated the water treatment plant.
•
• Designed SOPs, analytical test procdures and validation protocols.
• Managed customer complaints and product recalls. Maintained records of test results, inspection findings, and corrective actions taken.
•
• Spearheaded continuous improvement initiatives within the organization. Evaluated vendor performance against established criteria to ensure adherence to contractual obligations.
•
• Technical troubleshooting
• Customer complaint resolution
Laboratory equipment
maintenance
•
Quality management systems
(QMS)
•
• Workflow optimization
• Complex Problem-solving
• Quality Risk Management
• Vendor management
• Attention to detail
• Quality inspection
• Strong work ethic
• Cleaning validations
• Technology Transfer
• Outstanding trainer
November 2016 - November 2017
Quality Control Analyst Baxy pharmaceutical manufacturing company Ndola, ZM
December 2015 - November 2016
Quality Control Analyst Pharmanova Zambia limited Lusaka, ZM Conducted internal audits to ensure compliance with WHO and ISO 9001/17025 standards.
•
Investigated root causes of non-conformance issues and proposed solutions.
•
Ensured that all process changes were documented properly in accordance with company policy.
•
• Trained staff on quality control principles, techniques, and processes. Spearheaded method development and creation of a Quality Management System
•
Prepared detailed reports on quality performance metrics for management review.
•
Provided guidance on regulatory requirements related to Quality Control activities.
•
Performed regular inspections of raw materials, components, and finished products.
•
Managed calibration systems for equipment used in the laboratory and production departments.
•
Operated laboratory equipment such as balances, UV-Vis spectrophotometer, PH-meter and dissolution tester, AAS, FTIR, HPLCs and scheduled test procedures in accordance with SOPs
•
Monitored production processes to ensure compliance with established quality control standards.
•
Collaborated with cross-functional teams to develop solutions for identified issues related to product quality.
•
Compiled laboratory test data and performed both chemical and micibiological analyses such as MLT, sterility testing, Bacterial Endotoxin.
•
Ensured adherence to applicable regulations such as, WHO pharmaceutical guidelines, ISO 17025 and 9001 standards.
•
Created test plans for incoming raw materials prior to use in production lines.
•
Conducted routine and non-routine analyses of in-process materials and stability samples.
•
Identified and troubleshot equipment problems such as HPLC, UV-Vis spectrometer, FTIR etc.
•
Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
•
• Participated in SOP and analytical test method preparations. Performed analysis by spectrometric method, chromatographic techniques and wet chemistry
•
Monitored production processes to ensure compliance with established quality control standards.
•
Investigated customer complaints related to product quality and developed solutions accordingly.
•
• Compiled laboratory test data and performed analyses. Performed root cause analysis on non-conforming materials to identify problems and corrective action plans.
•
• Conducted routine and non-routine analyses of in-process materials and stability samples.
EDUCATION AND TRAINING
Expected in May 2026
Master of Science Medicinal Chemistry
The University of Zambia, Lusaka
December 2015
Bachelor of Science Chemical And Biological Sciences The University of Zambia, Lusaka
October 2009
High School Diploma
Mkushi Secondary School, Mkushi
ACHIEVEMENTS
Started quality control laboratories from system design, equipment qualifications, analysts validations to analytical method validations at kingphar and Yash lifeciences
•
• Certified against ISO 17025 standards
Implemented quality management system as per ISO 9001 and ISO 17025
•
Validated and commissioned type 2 water treatment at kingphar and Yash lifeciences limited
•
Shimadzu certified competent HPLC, GC, FTIR and UV-Vis spectrophotometer troubleshooter
•
CERTIFICATIONS
• ISO 17025 by SADCAS
• HPLC operation and troubleshooting by SHIMADZU South Africa
• FTIR operation and troubleshooting by SHIMADZU South Africa
• cGMP: CAPA and Root Cause Analysis by CROVIK TECHNOLOGIES
• Equipment calibrations and certifications by MICHEM DYNAMICS LANGUAGES
English: C2
Proficient
Tonga: C2
Proficient
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