PATIENCE ZITHA
QA & OHS OFFICER
Centurion
Summary
A position in quality, regulatory affairs and health and safety , production , or related area that offers key participation in a business, team oriented tasks, immediate challenges, and career opportunity
OHS professional with solid foundation in safety regulations and risk management. Experienced in implementing safety protocols and conducting thorough workplace inspections to ensure compliance. Known for strong team collaboration and adaptability in dynamic environments, delivering impactful safety training and hazard mitigation.
Engineering professional with proven ability to innovate and solve complex technical challenges. Known for delivering high-quality solutions and driving team success through effective collaboration and adaptability. Skills include systems analysis, project management, and technical troubleshooting.
Developed robust analytical and problem-solving skills in high-paced manufacturing environment. Demonstrated expertise in quality assurance and compliance with industry standards, ensuring high product quality and safety. Seeking to transition into new field, leveraging transferable skills to contribute to organizational goals and growth.
Overview
11
11
years of professional experience
Work History
QA & OHS Officer
Lodox Systems
Johannesburg
04.2024 - Current
- Identifying opportunities for process improvement, waste removal, and cost reduction.
- Implementation and maintenance of the playbook principles(Lean).
- Planning, facilitating, and executing continuous improvement events using Lean Six Sigma tools.
- Teaching, leading, and coaching cross-functional teams on Lean Six Sigma tools and methodology.
- Working to continuously improve processes both on the production floor as well as the rest of the departments.
- Evaluating and prioritizing potential improvements based on gains and required effort.
- Securing employee commitment for proactive change management
- Establishing a clear and well-articulated implementation plan for process improvement.
- Specifying obstacles and ways to overcome them through continuous improvement.
- Regularly monitoring the implementation of solutions to achieve objectives and expected benefits.
- Implementation of new Regulations as per requirements.
- Management of suppliers’ process: Onboarding, Evaluations and auditing of suppliers.
- Management of significant changes. Securing employee commitment for proactive change management.
- Ensuring that audits are conducted by means of scheduling, conducting and closing off audits.
- Management of corrective and preventative actions and non-conformances by ensuring that all CAPA’s and NCR's are investigated ,analyzing the root caused and ensuring that CAPA's and NCR'ss are closed in a timely manner and effective.
- Scheduling management review meeting and compilation and completion of the management review report in time for annual audit.
- Reporting of QMS trends or measuring the effectiveness of QMS.
- Manage,develop ,implementation of new QMS requirements and ensure compliance.
- Reduce customer complaints by proactively addressing product issues before release.
- Collaborate with cross-functional teams to identify areas of improvement in production processes.
- Develop comprehensive reports detailing test results, defect tracking, and corrective actions taken.
- Review technical documentation to ensure clarity, consistency, and conformance with established guidelines.
- Evaluated new tools and technologies that were successfully integrated into the existing QA framework enhancing overall capabilities.
- Collaborated effectively with suppliers to resolve any identified quality concerns or discrepancies in received materials.
- Ensure compliance with industry regulations by conducting regular audits of internal systems and processes.
- Implement root cause analysis techniques to identify recurring issues, leading to effective resolutions.
- Support product development teams by providing expert guidance on quality requirements during design stages.
- Develop and implemented procedures to meet product quality standards.
- Collect and analyzed data to measure effectiveness of quality control processes.
- Report problems and concerns to management.
- Review production processes and identified potential quality issues.
- Enhance workplace safety by conducting regular inspections and identifying potential hazards.
- Streamlining safety training programs for improving employee understanding and compliance.
- Collaborating with management to develop targeted safety initiatives, resulting in decreased accidents and injuries.
- Cultivating a strong safety culture within the organization through consistent communication and reinforcement of OHS expectations.
- Reducing incident rates by implementing comprehensive OHS policies and procedures.
- Maintaining accurate records of safety-related incidents, contributing to data-driven decision-making processes.
- Developing risk assessments for various job tasks, leading to the implementation of appropriate control measures.
- Providing support during external audits, demonstrating organizational commitment to safety best practices.
- Monitoring trends in occupational health and safety research, staying informed of best practices and emerging threats.
- Managing hazardous materials inventory, ensuring safe storage and disposal in accordance with regulatory requirements.
- Update OHS policies regularly to ensure alignment with changing industry standards and regulations.
- Advise on proper ergonomics in the workplace, reducing instances of work-related musculoskeletal disorders.
- Participate in cross-functional teams to address complex safety concerns, facilitating proactive solutions.
- Conduct thorough investigations of workplace incidents to identify root causes and prevent future occurrences.
- Improve employee awareness of safety regulations through engaging presentations and workshops.
- Monitor workplace activities to determine compliance with safety regulations and standards.
- Educate employees on hazardous waste management, emergency response and safe work practices.
- Conduct safety audits and inspections to identify workplace hazards and deficiencies.
- Investigate incidents, determining root causes and implementing corrective actions.
- Perform safety analyses to evaluate potential risks and develop risk mitigation strategies.
- Provide new-employee health and safety orientations and developed materials for presentations.
- Develop and implement safety policies and procedures to promote workplace safety.
- Identify accident causes and optimal prevention strategies by conducting thorough investigations and analyses.
- Research and devise new safety initiatives and strategies to improve safety performance.
- Devise and monitor safety performance metrics to assess and improve safety performance.
OHS & QA Specialist
Priontex SA
Johannesburg
02.2019 - 03.2024
- Quality Management System (QMS): Managing development, implementation of a robust ISO 13485:2016 accredited
- Ensuring compliance with QMS requirements
- Post Market Surveillance: Conducting post-market surveillance in line with company’s QMS
- Compliance: Ensuring that SAHPRA and GMP Guidelines are up to date, assisting with compliance of medical devices to relevant medical device regulations
- Regulatory: Researching new regulatory requirements, compile and disseminate information to relevant employees and conducting training on regulatory requirements
- Ensuring compliance to regulatory requirements in the following countries: EU-Maintain notified body accreditation of Priontex’s QMS
- Develop and maintain files (technical documentation) for CE marked devices
- Ensure the site successfully transition from MDD 93/42/ECC to MDR requirements
- Ensure compliance with local (SAHPRA) and international regulations with regards to legislative requirements for importing, manufacturing (including labelling), marketing, distribution and exporting of medical devices and any other products sold by the organization
- Ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA)
- Preparing documentation that are aligned with quality standards and country specific regulations and ensuring that submissions meet set deadlines
- Registering of Group products and/or all Group sites with local and international regulatory authorities
- Liaise and negotiating with local and international regulatory authorities in order to ensure that registration/Licensing for the organization is not delayed
- Outline requirements for labelling, packaging and storage in cases where regulatory requirements differ from current practices
- Ensure all licenses are within expiry and re-new before they expire
- Technical file & Risk Management: Maintain and ensure technical file for CE marked medical devices are up to date
- Ensure risk management is always up to date
- When new risk is identified, ensure risk management file is updated
- Change Control: Responsible for the organization‘s change control processes to ensure that implements and changes are validated and documented
- Validation of Projects and report writing namely (but not limited to): Validation of sterilization equipment which includes IQ, OQ & PQ for both steam and EO sterilization
- Validation of packaging (steam and EO) with regards to re-use, seal strength, dye penetration and effect of aging
- Validation of cleanroom particle counts
- Cleaning validation, Temperature and Humidity logger verification
- Audits: Coordinate internal and external audits, ensuring audit schedules are in place and executed to plan
- Communication: Communicate with notified bodies regarding audits scheduling, documentation and CAPA’s
- Supervision/Managing: Managing and monitoring ten in-process quality controllers to ensure that they are doing the right job and also to provide all necessary trainings
- Root Cause Analysis and CAPAs: Document, investigate the root cause and implement corrective and preventative action
- Deviations: Document, investigate and trend all deviations on site
- Quarantine: Manage on site quarantine process
- Customers: Document and participate in resolving customer complaints, communicate with customers regarding quality related issues
- Projects: Production Process Improvements (5s, Kanban, Hourly by Hourly Records, Value Stream Mapping, simulation, In-process quality checks, AQL)
- Labels: Designing and printing of labels
- Calibration: Ensuring that all company equipment’s are calibrated on time
- Batch Release: Reviewing and signing up and approving all batch documents and COC’S
- Supplier Management: Coordinate selection, evaluations and auditing of supplier to ensure that the company have proper suppliers as required by the standard
- Document Control: Responsible for all document control on site
- Making sure only effective documents are in the QMS and all superseded versions are archived
- Creating a yearly schedule for documents that are due for review, communicate with the process owners by e-mail a month before their documents are due for review
- Site OHS: Managing site Environmental Health and safety
- Ensure that site conforms to the Occupational Health and Safety Act (No
- 85 of 1993)
- Ensure that all applicable Health and Safety Policy and procedures are developed, implemented and maintained
- Ensuring that the site comply with all health and safety principles
- Conducting all related environmental health and safety risks assessments
- Managing and investigating all site incidents
- Implementing and monitoring all HSE management systems on site, including, but not limited to HSE guidelines, objectives and practices
- Scheduling and executing audits on site to identify areas of improvement and implementing measures as required
- Providing HSE training, awareness and induction on site to staff, contractors and other relevant parties
- Implementing accident-prevention and environmental impact activities on site
- Implementing emergency and crisis management plans on site
- Training: Providing necessary training relating to Quality, Regulations and OHS aspects when the need arises to the QCs in Production and as the need arises in other areas within Priontex or its key partners
- Meetings: Hosting weekly investigation review board meetings (IRB), Monthly quality meetings and management review meetings and ensuring that all actions are closed on time
Quality Control/assurance Engineer
Delberg Engineering (PTY) Ltd
01.2017 - 01.2019
- QMS: Implementing and maintaining requirements of Quality Management System ISO 9001; 2015, ISO 14001:2015 and ISO 45001:2018
- Involved in a Total Quality Management
- Audits: Preparation for and management of the yearly audit accordance to the accreditation body requirements
- Establishment of the annual schedule for the internal quality audits, carrying out of these audits according to ISO 9001 and ISO 19011
- Root Cause Analysis: Investigation of Non-conformances, and monitoring of Corrective and preventive actions
- Application of problem solving techniques
- Audit, liaison and development of supplier’s QMS prior and during the course of the contract
- Inspections: First article inspections (FAI)
- Ensuring that manufactured products are according to the drawing specifications
- Quality inspections on products and material
- Documentation: Ensuring that the processes are in suitable to the clients Policies, Procedures, Work Instructions and Specifications and where any of above has changed that they are updated and revised to reflect the chance
- Non-conformances: Raising Non-conformance reports (NCR) for internal products and incoming products from our suppliers
- Statistical monitoring of Non-conformances, Quality cost internal and external and monthly report back
- Problem Solving: Identifying and Solving production process problems on a daily basis
- Risk Management: Conducting failure mode and Effect Analysis (FMEA) for processes and products
- Projects: Implemented a 5s (Big project process improvements)
- Special Project (TPM) Total Preventative Maintenance
- Overall Effective Efficiency (OEE) and Single Minute Exchange Of Dies (SMED) to improve production efficiency
Records Management Assistant
Vhembe District Municipality
10.2015 - 10.2016
- Excel spread sheets and recording files
- Graphically presentation of records
- Preparing and reporting on records
- Typing (Editing, Deleting and Recording of Data)
- Archiving and Sorting Filles
Process Engineer Intern
Silverton Engineering
08.2014 - 09.2015
- Process Mapping and Modeling
- Time studies
- Updating Work Instructions
- Value chain and Implementation Support, Simulation of processes to identify bottlenecks and support business in the implementation of solutions
- Identification and project management of business process improvement initiatives
- Monthly Data analysis
Education
B-TECH - Industrial Engineering
TSHWANE UNIVERSITY OF TECHNOLOGY
TSHWANE NATIONAL DIPLOMA - Industrial Engineering
TSHWANE UNIVERSITY OF TECHNOLOGY, PRETORIA
Tshwane 04.2001 -
Diploma - Safety Management
UNIVERSITY OF SOUTH AFRICA (UNISA)
Certificate - SHEMTRAC (2020) SAFETY OFFICER TRAINING COURSE (TOP Student)
HASLAC
01.2020 - 12.2020
Certificate - Implementation of ISO 13485:2016 And MDR Training
IMS
04.2001 -
Certificate - ISO 13485:2016 Medical Devices :Internal Auditor
BSI
04.2001 -
Certificate - Implementation of The Medical Device Regulation (M
BSI
04.2001 -
Certificate - LEAN SIX SIGMA GREEN BELT
2KO
10-2024
High School Diploma -
New Era College
04.2001 -
Diploma - computer literacy
AVUXENI COMPUTER ACADEMY
Skills
- Ability to work under new technologies
- Innovation
- Leadership
- Ability to learn and adapt quickly
- Quality Control
- Quality Assurance
- Environmental Health and Safety
- Process Improvement
- Project Management
- Process Mapping
- Time and Work Studies
- Writing Procedures
- Writing Work Instructions
- Problem Analysis
- Problem Resolution
- Attention to Detail
- Planning Skills
- Organizing Skills
- Microsoft Word
- Microsoft PowerPoint
- Microsoft Excel (basics)
- Microsoft Visio (basics)
- Outlook
- Computer Aided Draught (CAD Basics)
- Report Writing Skills
- Presentation Skills
- Data Interpretation
- Regulatory Compliance
Phone Numbers
- 0810077825
- 0692215576
Id
9103191090086
Personal Information
- Age: 31
- Ethnicity: African
- Gender: Female
Driver License
Code 10
Timeline
QA & OHS Officer
Lodox Systems
04.2024 - Current
Certificate - SHEMTRAC (2020) SAFETY OFFICER TRAINING COURSE (TOP Student)
HASLAC
01.2020 - 12.2020
OHS & QA Specialist
Priontex SA
02.2019 - 03.2024
Quality Control/assurance Engineer
Delberg Engineering (PTY) Ltd
01.2017 - 01.2019
Records Management Assistant
Vhembe District Municipality
10.2015 - 10.2016
Process Engineer Intern
Silverton Engineering
08.2014 - 09.2015
NATIONAL DIPLOMA - Industrial Engineering
TSHWANE UNIVERSITY OF TECHNOLOGY, PRETORIA
04.2001 -
Certificate - Implementation of ISO 13485:2016 And MDR Training
IMS
04.2001 -
Certificate - ISO 13485:2016 Medical Devices :Internal Auditor
BSI
04.2001 -
Certificate - Implementation of The Medical Device Regulation (M
BSI
04.2001 -
High School Diploma -
New Era College
04.2001 -
Diploma - computer literacy
AVUXENI COMPUTER ACADEMY
B-TECH - Industrial Engineering
TSHWANE UNIVERSITY OF TECHNOLOGY
Diploma - Safety Management
UNIVERSITY OF SOUTH AFRICA (UNISA)
Certificate - LEAN SIX SIGMA GREEN BELT
2KO
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