Ntombozuko Nongogo
Raw Material And Packaging Supervisor
Johannesburg
Summary
Dynamic and detail-oriented professional with a National Diploma in Analytical Chemistry from Cape Peninsula University of Technology and ongoing studies in Total Quality Management from the University of South Africa. Nearly 15 years of pharmaceutical laboratory quality control experience, complemented by expertise in associated quality assurance functions within internationally recognized organizations. Currently serving as a Raw Material and Packaging Supervisor at Adcock Ingram Critical Care, demonstrating strong leadership in laboratory settings while maintaining a commitment to Good Laboratory Practice (GLP), Good Manufacturing (GM), and Good Distribution Practices (GDP). Recognized for exceptional troubleshooting skills with laboratory instrumentation, the ability to thrive under pressure, and a proven track record of meeting deadlines while ensuring compliance with industry standards.
Overview
20
20
years of professional experience
1
1
Language
1
1
Isixhosa
1
1
Isizulu
Work History
Raw Material & Packaging Supervisor
Adcock Ingram Critical care
08.2023 - Current
- Coordinate sampling of Raw material and packaging material.
- Prepared employee schedules according to individual needs and skills, as well as coverage requirements.
- Liaising with the Laboratory manager to ensure release as per agreed times.
- Review analytical notebook raw data for accuracy in testing by maintaining rigorous quality control standards and regularly calibrating equipment.
- Release Raw materials and Packaging Material on Oracle.
- Review analytical notebook raw data for accuracy in testing by maintaining rigorous quality control standards and regularly calibrating equipment.
- Ensure awareness of cGMP and cGMP among all personnel.
- Ensure that all Customer Complaints received for analyses are tested in accordance with relevant SOP.
- Adhered to laboratory safety procedures to maintain compliance with quality control standards.
- Tracking and investigating deviations to uncover root causes and make proactive changes to prevent future problems.
- Reviewing and confirming the compliance of test results ensuring adherence to product release specifications.
- Ensuring that the approval or rejection process raw material is handled in accordance with the required procedure.
- Ensuring all records relating to releases, retests or rejections are kept as well as the relevant number of retention samples.
- Assisting with ensuring that all specifications, test methods and other quality control procedures are available.
- Contribute to the development of new tests or methodologies through collaborative research efforts with colleagues or external partner.
- Compliance with cGMP and GLP requirements.
- Led improvement initiatives to advance operational efficiencies and increase revenue.
- Worked closely with quality assurance teams to address and resolve any discrepancies or concerns related to laboratory processes, data, or results.
- Promoted collaboration among team members through regular meetings, open communication channels, and team-building activities.
- Established a safe working environment by enforcing strict adherence to safety protocols and guidelines.
Development Analyst
Adcock Ingram
10.2017 - 03.2020
- Product Development.
- Testing of new product and reformulated products during development stage. Testing may include but is not limited to: Lab and Pilot Trials, Stress Studies, Compatibility Studies, Stability.
- Development of Analytical Methods for RD&I Projects and Factory Requests.
- Investigation.
- Process Validation.
- Development of Specifications and Methods.
- Method Validation for RD&I Projects and Factory Requests.
- Comparative Dissolutions.
- Raw Materials and Packaging Components Evaluation.
- Compilation of raw and packaging material specifications and methods.
- Release testing.
- Evaluation of alternate suppliers.
- Permeation Testing.
- Laboratory Compliance.
- SOP’s Compilation and training.
- Review and compilation of Documentation!
- Ensuring regulatory compliance in laboratory with local and international guidelines.
- Delegate Responsibilities.
- Responsible for instrument/equipment/process/procedures as delegated.
- Ad-hoc Requirements may include but is not limited to: Assistance to factories with routine release/stability testing, Assistance with regards to troubleshooting, Assistance with regards to customer complaint investigation.
Laboratory Supervisor
Johnson & Johnson Pharmaceutical
10.2014 - 04.2015
- Company Overview: (Cape Town)
- Evaluation of starting material for use in manufacturing.
- Testing of raw materials and finished products according to specified procedures.
- Testing completed on due dates.
- No of tests/chemist/day.
- Testing and comparing new source raw material.
- Testing and reviewing of RO Water for manufacturing.
- Testing and reviewing of Finished Product that are put in stability Program.
- Taking out samples.
- Planning and Prioritizing.
- Liaising and planning with different departments.
- Due dates for testing and QC Releases adhere to.
- Due dates for All CAPA open for laboratory Compliance.
- Risk Assessment.
- Good Analytical Laboratory compliance practice.
- Compliance with relevant GALCP and EHS SOPs and requirements SOP’s compiled and updated for instruments as required.
- Instruments calibrated as per procedure, Maintain of Housekeeping standard in the laboratory.
- No major CQA, EHS or ISO audit findings.
- SOPs updated timorously.
- Ensure training of Quality Control personnel is conducted in accordance with relevant procedure for relevant teams.
- Assist with performing performance assessments/reviews of all direct reports against agreed objectives.
- Analytical investigations.
- Investigation of OOS and OOT results in accordance with specified SOP.
- Analytical investigation completed within specified time frame and must be recorded.
- If no laboratory error discovered during an Analytical investigation a cross functional Investigation to be opened on symphony and closed on time.
- Initiate Change Control.
- Stability Testing.
- Testing of Finished product according to specified stability procedures.
- Stability testing completed within the specified time frame.
- Validation Testing.
- Testing of products according to procedures specified in validation protocol for Process, Cleaning and Utility studies.
- Validation testing is completed timorously.
- Support for Cross functional investigation (NC), Production Complaints investigation and special investigation.
- Development and execution of relevant test procedures for products to identify root cause.
- Identification of relevant test procedures and outsources somewhere in-house instrumentation is lacking.
- Investigation is timorously and successfully concluded with not out of stock situation.
- Adhere to Quality Systems requirements by making sure all open Investigations, CAPAS and GCC are closed timorously.
- (Cape Town)
Laboratory Analyst
Johnson & Johnson Pharmaceutical
06.2012 - 10.2014
- Company Overview: (Cape Town)
- Stability Testing / Bulk holding Studies.
- Testing of finished products as per specified stability procedures.
- Carrying Out investigations of OOT & OOS results as per specified SOP, s.
- Cleaning and Process Validation.
- Complies with relevant GALCP SOP’s.
- (Cape Town)
Laboratory Analyst
Adcock Ingram Critical Care
10.2011 - 05.2012
- In-process testing: Filter Changes and Downtime / Breakdown sample testing.
- Receive, Checking and logging samples arriving in the lab from the factory.
- Ensure testing is completed within 20mins.
- Following appropriate procedure if in-process specifications are not met.
- Final product testing.
- Testing of Customer Complaint samples.
- Testing of contaminants or Absence or unwanted ingredients in the samples.
- Preparation of Reagents, Standards, and standardization of volumetric solutions.
- Water sampling and water testing.
- INSTRUMENTATION USED: Flame photometer, HPLC, IR, Ph, AA, UV-VIS, and Auto titrator.
Laboratory Analyst
Merck Pharmaceutical
09.2010 - 09.2011
- Testing of raw material and finished goods products.
- Testing of all Chemical reagents before use.
- Adhering to GLP and GMP.
- Calibration of laboratory equipment before use and at the correct intervals.
Laboratory Analyst
Johnson & Johnson Pharmaceutical
03.2009 - 08.2010
- Company Overview: (Cape Town)
- Stability Testing / Bulk holding Studies.
- Testing of finished products as per specified stability procedures.
- Carrying Out investigations of OOT & OOS results as per specified SOP, s.
- Cleaning and Process Validation.
- Complies with relevant GALCP SOP’s.
- (Cape Town)
- INSTRUMENTATION USED: HPLC, GC, UV, Dissolution and Karl Fischer.
Laboratory Analyst
Aspen Pharmacare
09.2008 - 02.2009
- Company Overview: (East London)
- Testing of raw material and finished goods.
- Testing of all chemical reagents before use.
- Maintaining GLP.
- Calibration of laboratory equipment before use and at pre-determined intervals.
- (East London)
- INSTRUMENTATION USED: HPLC, GC, UV, Dissolution and Karl Fischer.
Laboratory Analyst
Fine Chemicals Corporation
07.2005 - 08.2008
- Stability Testing.
- Performing routine stability testing on finish products to provide additional evidence on how the qualities of the drug substances vary with time under the influence of the prescribed package and storage conditions, and to enable recommended retest dates and retest periods to be established. Four critical tests associated Assay, Chromatographic purity, loss on drying and water content.
- Production Support.
- Performing routine analytical test to monitor the quality of raw material, in-process samples finished goods products.
- Ensure that samples that are submitted to the laboratory are tested accurately and timeously.
- Regular Compliance.
- Ensure that tasks are performed in manner that is in compliant with GLP and that other Regulatory guidelines like MCC and FDA are adhered to.
Education
Grade 12 -
Thembalabantu High School
01.2002
Total Quality Management - undefined
University of South Africa
05.2016
ND - Analytical Chemistry
Cape Peninsula University of Technology
01.2006
Skills
Knowledge of aseptic processes
GMP and GLP compliance expertise
ISO 9001 quality management
Deadline focused
Cross-functional teamwork
Proficient in computer applications
Analytical issue evaluation
Effective time management
Skilled in MS Office tools
Skilled at managing multiple tasks
Operational productivity improvement
Analytical decision-making
Independent drive
Prioritization and scheduling expertise
Responsive to new challenges
Effective communication
Problem-solving skills
Clear communication
Quality management system implementation
Quality management expertise
Safety regulation adherence
Team guidance
Ongoing enhancement initiatives
Effective schedule coordination
Academic Details
Thembalabantu High School, King William Town,Grade 12, 2002-12-31,
Cape Peninsula University of Technology, ND: Analytical Chemistry, 2006-12-31, Mathematics 1, Physics 1, Chemistry, Computer and Communication skills, Analytical Chemistry & Practical 1, 2, 3, Inorganic & Organic Chemistry 2 and 3, Microbiology and Biochemistry (Fundamentals), Physical Chemistry 2 and 3, Chemical Quality Assurance & Chemical Processing Industries,
Skills Acquired
- Aseptic Manufacturing Knowledge
- GMP, GLP and Safety principles.
- Understanding of ISO 9001
- Understanding of Quality System Management (Change controls, investigation, Risk assessments, Deviations, Customer Complains and CAPA)
- Syspro Capturing.
- Understanding of ORACLE
- Understanding of SAP System
- Ability to perform root cause analysis.
- Understanding of LIMS systems
- Understanding of Calibration system
- Understanding of Data integrity (ALCOA)
- Ability to update and review specifications.
- Understanding of production requirements.
- Computer literacy
- SOP updates on Matrix.
- Good Communication and presentation skills
- Deadline driven.
- Problem solving
- Attention to detail.
- Good Team Player
Contact Numbers
0814873489, 0114948210
Email Addresses
- Nnongogo085@gmail.com
- Ntombozuko.nongogo@adcock.com
Personal Information
- Date of Birth: 5 August 1984
- Gender: Female
- Nationality: South African
References
Portia Twala,
0636855978
Bradford Bowers:
0820456301
Timeline
Raw Material & Packaging Supervisor
Adcock Ingram Critical care
08.2023 - Current
Development Analyst
Adcock Ingram
10.2017 - 03.2020
Laboratory Supervisor
Johnson & Johnson Pharmaceutical
10.2014 - 04.2015
Laboratory Analyst
Johnson & Johnson Pharmaceutical
06.2012 - 10.2014
Laboratory Analyst
Adcock Ingram Critical Care
10.2011 - 05.2012
Laboratory Analyst
Merck Pharmaceutical
09.2010 - 09.2011
Laboratory Analyst
Johnson & Johnson Pharmaceutical
03.2009 - 08.2010
Laboratory Analyst
Aspen Pharmacare
09.2008 - 02.2009
Laboratory Analyst
Fine Chemicals Corporation
07.2005 - 08.2008
Total Quality Management - undefined
University of South Africa
ND - Analytical Chemistry
Cape Peninsula University of Technology
Grade 12 -
Thembalabantu High School