Loshnee Vandayar

Experience

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  Lancet Laboratories - Bedford Gardens

  Jan 2008 - May 2009

  Med Tech - Second in Charge

  - leading a team of 4 day staff- assisting the Lab Manager in preparing for Sanas Accreditation- ensuring lab adheres to all technical SOPs- ensuring lab adheres to all H&S requirements- advanced troubleshooting on the ffg instrumentation: Integra 400+ Sysmex XS and XT Alifax ESR Sysmex CA560- customer relationship management with both Doctors and patients- customer complaint management in the absence of the lab manager- extensive management of documentation- supervising the completion of documentation by staff according to working instructions- internal quality control management- advanced quality control troubleshooting Show less

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  Lancet Laboratories

  Jun 2010 - Dec 2015

  Managing a technical team of 8 day staff and 2 night staffManaging an admin team of 11 day staff (including admin supervisor) and 3 night staffPreparing for and ensuring successful SANAS Accreditation (ISO15189)Ensuring lab follows and adheres to all Lancet SOPs and working instructionsEnsuring documentation completion adheres to ISO15189 and WI'sInternal and external quality control management Procurement managementTalent development and staff retentionTraining and upskilling of all staffPerformance managementStrategic and operational planningSetting of quarterly and annual objectives and goalsProviding and implementing action plansMonitoring of all action plans for target/goal achievementAnnual Management reviewCarrying out inter laboratory internal audits between sister labsDecision makingBudgeting and cost controlCustomer relationship management with Drs, patients and corporate clientsAdvanced knowledge and troubleshooting of instrumentation including:Sysmex XT 2000Sysmex CA560COBAS 6000BilirubinometerRoche Cardiac H232Biomerieux Mini. VidasAlifax ESRAbility to have a 360 degree view of the entire service the lab provides and foresee potential risks and areas of improvement. Show less Leading a team of 4 day staff Ensuring all staff adhere to all SOPs and working instructionsEscalating to lab manager should SOPs and WI's not be followedTroubleshooting of all instrumentation including:Sysmex XS and XTIntegra 400+Alifax ESRBilirubinometerSYsmex CA560Roche Cardiac H232Biomerieux Mini VidasInternal and external quality control management Monthly rosters and duty allocation Ensuring all H&S protocols are followed Technical dutiesExtensive knowledge of equipment Advanced troubleshooting of equipment Show less

  • Lab Manager

    Jun 2013 - Dec 2015

  • Laboratory Manager

    Jun 2010 - May 2013
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  DiaSorin

  Aug 2016 - Oct 2018

  Ensuring that the site Validation/Calibration System is in compliance with Corporate Quality System requirements and recognized international standards. Measure, analyse and calibrate equipment and/or processes to ensure highest quality products are made consistently. Compilation of all validation protocols and reports on site and guiding the evaluation and validation of new equipment and methods to ensure standardization and continuous technological advancement. Project management and planning of all site projects involving validation. Major Accountabilities: Maintain and coordinate the existing DiaSorin South Africa Validation Program to ensure continued compliance and improvement. Participate and provide feedback to the Site Validation Review Board.  Lead the rollout of the S-VMP and on an ongoing basis for all site validations. Participate in site project/s Cross Functional Teams (CFT’s), from a Validation subject matter expert perspective, to ensure adherence to required validation policies and procedures, including safety and training. Preparation of validation protocols and reports. Pre-approve and post-approve validation protocols; assessments and conclusions. Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Trials (FAT’s) and any other associated validation issues. Collate and provide relevant Validation data / metrics for management review and monthly highlight reports. Validation Training for the site.  Managing the site calibration schedule and all instruments calibrated on site and off site. Calibrating specific instruments on site e.g. pipettes, washers, readers etc. Manage areas of responsibility to foster safety awareness as required by the site EHS program. Preparation for audits, maintenance of current status, document updates, to ensure that accreditation is achieved or obtained in line with organizational objectives. Show less Manufacturing of rare reagents.Adhering to service levels and quality standards, in accordance with the principles of Good Manufacturing Practice, TUEV accreditation requirements, Quality assurance including quality control, health and safety, Process operating instructions, turn-around time targets etc.Preparation for audits, maintenance of current status, document updates, to ensure that accreditation is achieved or obtained in line with organisational objectives.Ensuring that the equipment used in the laboratory is operating efficiently and providing accurate results. This includes ensuring that instrument maintenance and quality control results are recorded and reviewed as well as trouble shooting and corrective action is taken and documented.Ensuring all correct functioning of Software programs and interfaces. Advanced knowledge of all software systems within the laboratory environment.Providing input into evaluation and validations of new equipment and methods to ensure standardization and continuous technological advancement.Overseeing asset management and procurement of goods to ensure the most effective utilisation of resources, optimisation of stock levels and cost containment.Generating experimental reports as required to investigate and troubleshoot problems and taking corrective action when required.Performing investigations into and resolution of customer complaints to ensure a positive image of the organisation by clients and patients and to promote the services of the company.Complying with professional registration requirements. This includes ensuring the availability of up to date records that can be presented immediately on request thereof.Adhering to professional conduct requirements in line with organisational policy and relevant professional body ethical standards.Performing the role of a Technical analyst as required in accordance with operational needs. Show less

  • Validation Specialist

    Oct 2017 - Oct 2018

  • Technical Analyst

    Aug 2016 - Sept 2017
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  PRIONTEX MICRONCLEAN

  Nov 2018 - Sept 2019

  National QA and RA Manager

  Managing quality and regulatory affairs for 4 sites in Southern Africa. Certified to ISO13485 and ISO9001.

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  Cepheid

  Oct 2019 - now

  Responsible for regulatory project deliverables, timelines, and submission activities for new product development (NPD) and sustainment projects.Develop and implement strategies for timely submission and approval in Middle East and AfricaLead regulatory activities for NPD and Sustaining projects including planning, preparing, and submitting regulatory submissionsManage, guide, coach and lead a team (including other RA Managers)Supervise submissions of staff and direct reports who are responsible for regulatory submissions in Africa and Middle East regionsEstablish and review Regulatory Affairs priorities as they relate to department and company goals and objectivesProvide proactive regulatory intelligence in areas of a competitive nature and keep abreast of changes in agency regulations and requirementsInteract with global regulatory leaders and peers to expedite approval of pending registrationsProvide regulatory assessments for anticipated analytical, manufacturing and packaging changes and sustainment projectsProvide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials as neededProvide regulatory training to cross-functional groups as neededHave a strong foundation in the regulatory profession, including scientific, legal, policy and regulatory process management. Have well-developed regulatory technical knowledge and skills. Show less

  • Senior Manager, Regulatory Affairs, Global Market Expansion (METAP, EE, CIS and Balkans)

    Oct 2022 - now

  • International Regulatory Affairs Manager

    Oct 2019 - Sept 2022