Selepe Daniel Chabangu

Experience

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  Norvatis

  Feb 2001 - Mar 2004

  Tabletting Technician
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  Pharma Natura

  Apr 2004 - Mar 2005

  Tabletting Technician
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  Adcock Ingram

  Jul 2006 - Jul 2007

  Quality Assurance Inspector

  To provide the necessary assurance that all stages of manufacture comply with GMP, MCC and PIC-S legislative requirements and to perform specified tasks as delegated by the QA Pharmacist to ensure a quality product.Ensure overall GMP compliance in Production.Packaging In-Process Packing Line Inspections and assist with on-line queries & discrepanciesAll independent in-process checking of manufactured Product to ensure the product complies to specification.To check line clearance in packing is done correctly and the packing line is cleaned according to Company Procedure P13.1.Rejection of any faulty packaging material or finish product not found to comply with the specificationsTo carry out internal audits of your areas of responsibility at least once a month and to report your findings in writing to the QA Pharmacist, QA Manager and Responsible Departmental Head of department being audited. Ensure the implementation of the recommendations made as a result of the internal and external audit reviews.Weekly GMP Audit of random Packaging Lines or DepartmentsSamples all packed product according to a Sampling Plan, where there is an Out of Specification results and submit samples to the LabInput into customer Complaints as to possible source of the complaintInspection of Finish Product Samples and compile the report for Lot ReleaseAssist in on-line training of Temporary ColleaguesAssist with the execution on all Packaging Trials (ICC Light-weight Trial/ Label Glue Trial / etc.)To perform the isolation and destruction of rejected material and products on request from the QA Pharmacist.To ensure that operators comply with the relevant protective clothing and safety requirements, for example, overalls, hats, aprons and gloves at all times.To ensure that protective wear, (i.e. ear muffs, facemasks, goggles) is worn when required.To ensure correct temperature & Humidity monitoring and cleaning logs by production staff. Show less

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  Adcock Ingram healthcare Clayville

  Jan 2007 - Jan 2013

  Validation Officer

  Qualification and requalification of equipment’s, utilities and facilities (i.e. IQ, OQ and PQ) HVAC.Ensuring that all systems including: utilities, facilities, manufacturing processes, cleaning, filling and packing are validated in accordance with applicable Validation/Qualification protocols and guidelines.Validation of manufacturing processes (i.e. Preparing protocols and execution of protocols, writing reportsAccurately and timorously performing validations as per the validation scheduleReporting non-conformances during the manufacturing processes to relevant department managers and the QA managerRecommending changes to manufacturing processes, equipment and procedure to relevant managersEnsuring that all relevant sop’s are updated and trainedAssisting in performing internal audits when required Maintaining all qualified systems by ensuring that all periodic reviews and re-qualifications are performed as scheduled.Calibrations and monthly plans Show less

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  Adcock Ingram healthcare

  Aug 2013 - May 2015

  Validation Coordinator

  Qualification and requalification of equipment’s, utilities and facilities (i.e. IQ, OQ and PQ) HVAC.Ensuring that all systems including: utilities, facilities, manufacturing processes, cleaning, filling and packing are validated in accordance with applicable Validation/Qualification protocols and guidelines.Validation of manufacturing processes (i.e. Preparing protocols and execution of protocols, writing reportsAccurately and timorously performing validations as per the validation scheduleReporting non-conformances during the manufacturing processes to relevant department managers and the QA managerRecommending changes to manufacturing processes, equipment and procedure to relevant managersEnsuring that all relevant sop’s are updated and trainedAssisting in performing internal audits when required Maintaining all qualified systems by ensuring that all periodic reviews and re-qualifications are performed as scheduled. Show less

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  Fresenius Kabi SA

  Jun 2015 - Apr 2020

  Validation Officer

  Qualification and requalification of equipment, utilities and facilities (i.e. IQ, OQ and PQ) HVAC.Ensuring that all systems including: utilities, facilities, manufacturing processes, cleaning, filling and packing are validated in accordance with applicable Validation/Qualification protocols and guidelines.Validation of manufacturing processes (i.e. Preparing protocols and execution of protocols, writing reportsAccurately and timorously performing validations as per the validation scheduleReporting non-conformances during the manufacturing processes to relevant department managers and the QA managerRecommending changes to manufacturing processes, equipment and procedure to relevant managersEnsuring that all relevant sop’s are updated and trainedAssisting in performing internal audits when required Maintaining all qualified systems by ensuring that all periodic reviews and re-qualifications are performed as scheduled.Calibrations and monthly plans• Qualified & knowledge of the equipment’s: HSM, FBD, Granulators, PIAB Vacuum system, DCB, Compression machines, De-duster, Metal detector, Encapsulation machine, coating machine, container cleaner machine, Silica gel inserter, Tablet counter, Capping machine, labeling machine, Induction sealing machine, cartoning machine, shrink wrapper & liquid manufacturing equipment’s ,Work station Isolators,Transfer Isolators,Man sterilizers,Waste bins,Emergency drums,Incubators,Autoclaves,BacT machines,Endosafes.• Operation Knowledge of Instrument’s: Particle counter, Hot wire Anemometer, Vane Anemometer, Flow hood, DOP photometer, Multi meter, Tachometer, Stroboscope, Temperature & RH Data loggers, Microbial air sampler & Light meter. Show less

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  Triton Pharmaceuticals

  May 2020 - now

  Validation and Calibration Officer
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  Cipla South Africa

  May 2022 - now

  Deputy Manager QA-Validations