
Timeline
About me
Validation Officer Aspen SA Ops
Education

Vaal university of technology
2017 - 2019Btech biotechnology
Vaal university of technology
2012 - 2013National diploma in biotechnology biotechnology\microbiology\food technology national diplomaActivities and Societies: GTI Choir member from VUT.

Alison
-Qms quality assurance
O
2012 - 2013National diploma in biotechnology biotechnologyA member of Choir * Vaal University of Technology*
Experience

Newport juices
Mar 2014 - Mar 2015Trainee qc lab technicianDuties under Microbiology:• Preparations of solution , micro media, micro testing of incoming water sample, swab analysis which include ATP swabs, hands swab and normal swab• Micro testing of packaging, i.e, caps and bottles• Micro testing of shelf- life samples• Organoleptic sample of retention samples• E.coli testing and micro testing on after pasteurized sampleDuties under Chemistry:• Mixing and on-line sample testing including the following;BrixTitratable AciditypHTemperature checksTaste• Calibration and monitoring of lab equipment e.g. the brix meter( refractometer), incubators, scales and fridges• CIP chemical concentration using test kidDuties under Quality Assurance:• Factory Inspection which include the followings:Glass and Plastic checklistForeign object checklistGMP checklistOther duties:• Monitoring of Ozone readings• Collection of Raw Materials and Aseptic sample for biological testing and chemical testing• Customer complain treaceability Show less

Kingsley beverage
Jun 2015 - Feb 2018Qc lab technicianDescription of duties• Chemical and Microbiological testing of the product and raw materials• Calibration and control of lab instrument• Basic maintenance of lab equipment• Monthly report on the Nonconformance and corrective action• Housekeeping in the lab• Product release and Carbonation testing• Sensory evaluation of products• Taking and handling of samples• Seam checking• Water testing/ water treatment

Adcock ingram
Mar 2018 - Mar 2019Validation officerValidation and qualification(IQ, OQ, PQ) requirements for facilities, utilities and equipment ensuring cGMP compliancyEnsuring that the all equipments are validated and qualified to meet cGMP and GLPDeveloping and determining validation criteria for new equipment and or facility upgradeExecution of cleaning validation protocolsDrafting and Executing Sanitizer efficacy verification protocol in Microbiology labQualification of lab equipments, eg analytical balances and laboratory glassware washerCompilation and updating of validation documentsPerforming action required by quality management system including change control, deviation, non-conformance and risk assessmentCoordination of the validation protocols/reports for approvalTemperature mapping Show less

Adcock ingram critical care (pty) ltd.
Nov 2020 - Feb 2021Validation coordinator• Performing equipment Qualification on existing and new equip per SOP/PIC/SAHPRA requirement• Preparation and execution of validation protocol• Involved in a continues improvement • Performing Cleaning Validation studies/hold time studies• Working in compliance with cGMP• Periodic reviews on existing equipment• Quality Steam testing

Msd south africa
Mar 2021 - Sept 2021Validation specialist• Back-up sub-system owner for QMS Chapter 13 - Cleaning Validation and Chapter 17 -Equipment Qualification.• Contributes to authoring, updating and execution of the Site Validation Master Plan (VMP)• Planning and execution of Equipment Qualification and Cleaning Validation activities in collaboration with the equipment/process owners, supporting contractors and vendors• Authoring, updating and/or reviewing standard operating procedures for Equipment Qualification and Cleaning Validation• Authoring and/review of Equipment Qualification & Cleaning Validation protocols and reports• Assessing equipment, utility and/or facility changes for Qualification and Cleaning Validation impact• Contributing to the execution of the periodic review program for Equipment Qualification and Cleaning Validation to ensure qualification/validation status remains valid• Participating in internal collaborations through Equipment Qualification and Cleaning Validation Communities of Practices (CoP)• Developing change controls in collaboration with IPT and quality teams, as required• Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs) product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that you become aware of to the Designated Point of Contact (DPOC) Show less

Aspen pharma group
May 2022 - nowValidation officer*Performing validation exercises in compliance with GMP standards and validation schedules.*Maintaining compliant status of equipment and processes (systems, cleaning)*Performing the relevant operational qualification protocols as per SOP to ensure new equipment/utilities/ packaging function as per intended use.*Performing the relevant performance qualification protocols as per SOP to ensure new equipment/utilities/ packaging function as intended over time and within limits.*Investigating and reporting OOE results and perform re-tests.*Participating in change control assessments to ensure compliant status of affected equipment is notcompromised.*Conducting routine inspections of equipment and utilities to identify any deficiencies and ensurequality standards are being adhered to.*Ensuring documents and procedures to operate and maintain equipment are in place.*Assessing and recommending re-qualification of equipment and utilities as appropriate as per Protocol.*Preparing and performing re-qualification of equipment and utilities as per SOP.*Compiling, maintaining and updating validation documentation as per SOP and QMS.*Performing Cleaning Validation studies, Protocol and execution .*Generating validation reports on a weekly/ monthly basis. Show less
Licenses & Certifications

National diploma certificate in biotechnology
Sept 2015
Baccalaureus technologiae
Vaal university of technologySept 2019
Six sigma black belt certification – level iii
Training leadership consultingSept 2024
Languages
- enEnglish
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