Simoonga Mulunda
Chikankata-Southern 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.
Excel in critical thinking, problem-solving, and communication, ensuring seamless operations and continuous improvement across all quality systems.
Overview
9
9
years of professional experience
Work History
Quality Control Head
Yash Life Sciences Limited
Kafue, ZM
10.2018 - Current
- Manage a team of Quality Control Technicians responsible for analysis of raw materials, intermediates and finished pharmaceutical products.
- Lead regulatory and internal audits.
- 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 of product failures or non-conformances.
- Establish product specifications and quality assurance practices.
- Develop and implement quality control processes to ensure product compliance with industry standards.
- Assist in developing company-wide goals for improving product quality while reducing costs
- 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.
- Coordinate with suppliers to ensure that materials meet required specifications.
- Conduct regular audits of production operations to identify system gaps for improvement.
- Create detailed reports on the performance of quality control measures and present findings to senior management.
- Develope and implement quality control processes to improve product reliability.
- Train personnel in proper analytical techniques and methods used in the quality control process.
- Investigate customer complaints regarding product issues, analyze data, provide recommendations for resolution.
- Provide technical expertise regarding product design changes or modifications based on customer feedback.
- Oversee the development of new products, ensuring that all design requirements were meet prior to production.
- Provide support and guidance to colleagues to maintain a collaborative work environment.
- Conduct routine maintenance and repairs on sophisticated analytical instruments.
- Utilize advanced technical skills and expertise to troubleshoot complex problems and implement solutions.
Quality Control Manager
Kingphar Zambia limited
Lusaka, ZM
11.2017 - 10.2018
- Supervised and guided inspectors, technicians, and other staff.
- Handled scheduling procedures for department and directed team members in setting and achieving goals.
- Collected and analyzed production samples to evaluate quality.
- Fielded customer complaints and rectified service issues.
- Maintained records of test results, inspection findings, and corrective actions taken.
- Monitored product trends and suggested changes.
- Supported continuous improvement initiatives within the organization.
- Evaluated vendor performance against established criteria to ensure adherence to contractual obligations.
- Reviewed customer complaints and took corrective action when necessary.
- Conducted internal audits to ensure compliance with ISO 9001 standards.
- Coordinated with production team to ensure products meet specifications.
- Investigated root causes of non-conformance issues and proposed solutions.
- Ensured that all process changes were documented properly in accordance with company policy.
- Developed and implemented Quality Control policies and procedures.
- 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, hardness testers and dissolution tester,HPLCs and scheduled test procedures in accordance with SOPs
- Oversaw water safety processes, audits, corrective actions and chemical and micibiological quality.
Quality Control Analyst
Baxy pharmaceutical manufacturing company
Ndola, ZM
11.2016 - 11.2017
- 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 or service quality.
- Trained employees in proper equipment use and product testing procedures.
- Compiled laboratory test data and performed both chemical and micibiological analyses such as MLT, sterility testing, Bacterial Endotoxin.
- Ensured adherence with applicable regulations such as, WHO pharmaceutical guidelines, ISO 17025 and 9001 standards.
- Reviewed, analyzed and documented data related to quality assurance processes.
- Created test plans for incoming raw materials prior to use in production lines.
- Investigated or reported questionable test results as per OOS procedures.
- Documented inspection results according to established protocols including detailed reports outlining any potential defects or discrepancies found during review process.
- Provided technical support by troubleshooting equipment malfunctions during analysis.
- Trained other analysts to perform laboratory procedures and assays using analytical instruments such as HPLCs, dissolution tester, UV-Vis spectrometer, Karl Fischer tritrator.
- Conducted routine and non-routine analyses of in-process materials and stability samples.
- Inspected finished goods prior to shipment ensuring conformity with customer requirements.
- 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.
Quality Control Analyst
Pharmanova Zambia limited
Lusaka, ZM
12.2015 - 11.2016
- Developed and validated analytical methods
- Prepared samples, and Laboratory standards using specialized laboratory tools, apparatus and chemicals.
- Performed analysis by spectrometric method and chromatographic techniques
- 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 or service quality.
- Investigated customer complaints related to product quality and developed solutions accordingly.
- Monitored production processes to ensure compliance with safety regulations.
- Compiled laboratory test data and performed analyses.
- Reviewed, analyzed and documented data related to quality assurance processes.
- Investigated or reported questionable test results.
- 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
Bachelor of Science - Chemical And Biological Sciences
The University of Zambia
Lusaka 12-2015
High School Diploma -
Mkushi Secondary School
Mkushi10-2009
Master of Science - Medicinal Chemistry
The University of Zambia
Lusaka Skills
- Problem-solving
- Goal and quality oriented
- Excellent communication
- Computer proficiency
- Analytical method development and validation
- Regulatory compliance
- Quality assurance practices
- Root cause analysis (RCA)
- Process improvement
- Internal audits
- Team management
- Employee training
- Technical troubleshooting
- Customer complaint resolution
- Laboratory equipment maintenance
- Quality management systems (QMS)
- Quality metrics monitoring
- Communication skills
- Technical reporting
- Decision-making
- Quality assurance management
- Workflow optimization
- Complex Problem-solving
- Product Inspections
- Risk assessment
- Change management
- Policy reinforcement
- Vendor management
- Critical thinking
- Attention to detail
- Quality inspection
- Strong work ethic
- Outstanding trainer
Affiliations
- Chemistry Society of Zambia (CSZ)
- Chemistry Society - CBU
References
- Mr Mvhula Dubani, Senior Head Geologist, African Metals and Mining ltd (AMML), +260975686812
- Dr. Murari Dadi, Chemistry project supervisor, The Copperbelt University (CBU), +260976806235
- Mr Moonga N, Analytical Lab superintendent, Academy Consultancy Laboratory Services, +260760733655
Equipment
- Atomic Absorption Spectrometer (AAS)
- Friabilator
- X-Ray Fluorescence spectrometer (XRF)
- Dissolution tester
- HPLC Systems
- Hardness tester
- UV-VIS Spectrophotometer
Analytical Knowledge Modules
- Testing and Calibration Laboratories - ISO 17025:2017
- Quality Management Systems QC/QA- ISO9001:2015
- Sampling, Qualitative and Quantitative Measurements
- Environmental Management Systems- ISO 14001:2007
- Safety and Risk Management- ISO 31000:2009
Languages
English
Proficient
C2
Timeline
Quality Control Head
Yash Life Sciences Limited
10.2018 - Current
Quality Control Manager
Kingphar Zambia limited
11.2017 - 10.2018
Quality Control Analyst
Baxy pharmaceutical manufacturing company
11.2016 - 11.2017
Quality Control Analyst
Pharmanova Zambia limited
12.2015 - 11.2016
Bachelor of Science - Chemical And Biological Sciences
The University of Zambia
High School Diploma -
Mkushi Secondary School
Master of Science - Medicinal Chemistry
The University of Zambia