Omphile Phokontsi
Calibration Technician
White river
Summary
Diligent Calibration/Validation officer with solid background in calibration techniques and maintenance of precision instruments. Proven ability to ensure accuracy and reliability of measurement equipment, contributing to enhanced operational efficiency. Demonstrated proficiency in troubleshooting and repairing complex devices, showcasing strong analytical and technical skills.
Overview
1
1
Language
2
2
Certifications
9
9
years of professional experience
Work History
Calibration Technician
Wildlife Pharmaceutical (Pty) Ltd
10.2024 - Current
- Calibration of Instruments/Equipment/Measuring Devices
- Perform calibration, verification, adjustment and troubleshooting of laboratory, production and utility instruments in accordance with approved SOPs and GMP requirements.
- Calibrate balances, pressure gauges, pressure transmitters, Magnehelic gauges, temperature sensors, RTDs, thermocouples, conductivity, pH, temperature data loggers, dissolution testers,vernier calipers and other critical measuring equipment.
- Evaluate calibration results, perform impact assessments for out-of-tolerance instruments and maintain calibration records and schedules.
- Equipment Qualification (IQ/OQ/PQ)
- Prepare, review and execute Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols for GMP equipment.
- Participate in qualification of laboratory and manufacturing equipment including particle counters, drying ovens/boxes, incubators, refrigerators, freezers and other critical process equipment.
- Perform commissioning support, protocol execution, deviation documentation and final qualification reporting.
- Autoclave Qualification and Thermal Validation
- Prepare and execute empty and loaded heat distribution and heat penetration studies.
- Perform autoclave mapping using calibrated thermocouples and data acquisition systems.
- Conduct biological indicator and chemical indicator qualification studies.
- Analyse thermal mapping data and compile GMP-compliant qualification reports.
- Temperature & Environmental Mapping
- Perform temperature and humidity mapping of warehouses, refrigerators, freezers, incubators and controlled storage areas.
- Develop mapping protocols, execute studies, analyse results and prepare final reports.
- Verify environmental conditions comply with predefined acceptance criteria and regulatory requirements.
- Cleaning Validation and Cleaning Verification
- Execute cleaning validation and cleaning verification protocols for manufacturing equipment and product-contact surfaces.
- Perform rinse and swab sampling following validated sampling plans.
- Evaluate clean hold time and dirty hold time studies.
- Investigate deviations, assist with root cause analysis and prepare validation reports.
- Process Validation and Hold time studies.
- Execute process validation protocols for pharmaceutical manufacturing processes.
- Support sampling activities, data collection, statistical evaluation and preparation of validation reports.
- Compressed Gas Qualification
- Perform compressed air and nitrogen quality testing for moisture, oil, viable microorganisms and non-viable particles in accordance with GMP requirements.
- Operator Qualification
- Execute operator qualification studies for critical GMP processes and equipment.
- Assess operator competency through protocol execution and documented performance evaluations.
- Validation Documentation
- Prepare and review validation protocols, reports, risk assessments, deviations, CAPAs and change control documentation.
- Ensure all validation activities comply with GMP, ALCOA+ data integrity principles and company procedures.
- Calibration & Validation Program Management
- Maintain calibration and qualification schedules for facility equipment.
- Coordinate external calibration service providers and ensure traceability of reference standards.
- Support internal and external audits by providing calibration and validation documentation.
- Cross-functional Support
- Work closely with API and FPP Production, Technical Operations, Quality Assurance and Quality Control departments to support qualification, validation, investigations and continuous improvement initiatives.
Validation and Calibration Coordinator
Pharma-Q (Pty) Ltd
11.2020 - 09.2024
- Calibration of Instruments/Equipment/Measuring devices
- Calibration of measuring devices such as balances/scales, pressure gauges, pressure transducers, magnehelic gauges, temperature probes, temperature chart recorders, conductivity sensors, ozone sensors, chlorine sensors, ORP sensors, carton counter, label counters, stirrers, vernier caliper, dissolution apparatus, disintegration apparatus, fribulator, Hardness tester, thermohygroclocks, temperature dataloggers etc.
- Testing of compressed air and Nitrogen:
- Compressed air and nitrogen tested for moisture, oil, microbial and non-viable particle count as per the SOP
- Temperature mapping:
- To perform the temperature mapping in fridges, freezers, incubators, autoclaves and warehouse etc.
- To prepare the protocol for temperature mapping.
- Stability Chamber Mapping:
- To perform the temperature and humidity mapping of the stability chambers
- To prepare the protocols for stability chamber mapping
- Calibration Management
- Management of calibration schedules across the facility.
- Process Validation:
- To prepare and execute the process validation protocols
- Cleaning Validation:
- To execute the cleaning validation protocols
Calibration Coordinator
VR PAI’S (Pty) Ltd
09.2017 - 10.2020
- Calibration of the measuring devices, instruments such as balances, gauges, temperature probes etc.
- Preparation of schedule for calibration (Calendar)
- To communicate and share the plan of the schedule with calibration assistants and department mangers
- Coordinate with quality control lab and ensure all the equipment in the lab are calibrated as per the calibration program
- To arrange for the calibration by the external contractors if necessary
- Ensure that masters/references used for calibration are in calibrated state and traceable to recognized standard
- To order and store necessary calibration standard used for the calibration of equipment
- To review the calibration reports
- Ensure that all the equipment/devices are calibrated and calibration program/schedule is up to date
- Coordinating with the technical service department in the event of any failure of the equipment/utilities/system
- Software’s used: Syspro, Ebro, LogTag, Huato and Hobo
- (Working Sites- Pharma-Q (Pty) Ltd & Eurolab ASU)
Education
Grade 12 -
Batswana Commercial Secondary School
Mahikeng12-2009
Skills
MS Office (Word, Excel and Power point)
Tolerance calculations
Electrical troubleshooting
Quality control procedures
Test equipment operation
Precision measurement
Instrument Calibration
Equipment repairs
ISO standards
Certificate writing
Pressure calibration
Birth certificate processing
Excellent communication
Reliability
Attention to detail
Calibration software
Certification
Quality management systems: ISO 9001: 2015(DQS Training Academy) Transport Validation
References
- Siva Kiran, Thokala, Project Manager, +27 64 425 9186, 011 247 1600, Pharma-Q (Pty) Ltd
- Rajesh, Pai, Validation Manager, +27 79 461 8031, VRPAI PTY LTD
- Mulisa, Mathelemusa, Validation Officer, +27 63 200 0746, Wildlife pharmaceuticals Pty Ltd
- Coaster, Musandiwa, FPP Production Manager, +27 65 911 2071, Wildlife pharmaceuticals Pty Ltd
Timeline
Calibration Technician
Wildlife Pharmaceutical (Pty) Ltd
10.2024 - Current
Validation and Calibration Coordinator
Pharma-Q (Pty) Ltd
11.2020 - 09.2024
Calibration Coordinator
VR PAI’S (Pty) Ltd
09.2017 - 10.2020
Grade 12 -
Batswana Commercial Secondary School