Summary
Overview
Work History
Education
Skills
References
Timeline
Generic

SIVENATHI SIKAMBULE

Business And Statutory Compliance Specialist
Midrand,GP

Summary

Highly accomplished Business and Statutory Compliant Specialist with 16 years of diverse experience spanning manufacturing, packaging, quality, and currently supply chain management at Johnson and Johnson. Demonstrated expertise in effectively overseeing teams, budgets, and timelines, ensuring that projects are completed on time and within financial parameters. I hold an Advanced Diploma in Finance Management, alongside Diplomas in Chemical Engineering and Packaging, as well as a Higher Certificate in Quality. My strengths lie in problem-solving and devising robust processes that enhance organizational efficiency, which has contributed to my career advancement. I am also a dedicated team player who is passionate about fostering improvements and growth across the entire organization, rather than limiting my focus to a single functional department.

Overview

16
16
years of professional experience
3
3
Languages

Work History

Business and Statutory Compliance Specialist

Johnson and Johnson
01.2023 - Current
  • Overall import & export process control: documents check, customs clearance monitoring, shipments tracking, communication with customs brokers and customs authorities
  • Updating budget vs actual spend for each event. Driving the process around discrepancies if spend is more than budgeted for by getting the business to complete necessary documentation and recording information in HCC Life
  • Review overall information post events in HCC Life including, planned attendance vs actual attendance, travel dates vs. actual dates, ensure signed agreements are in place, ensure the necessary evidence, attendance certificates, records of use, confirmation of service documents, employer notifications as per MedTech requirements are uploaded and that they are complete and accurate
  • Tracking and reporting any deviations to the process
  • Track Grant reconciliations from the institutes. Additionally correct information (dates) is provided for all 3rd party requests i.e Grants and Fellowships
  • Review all planned HCC payments before a PO is raised. Make sure HCC approval is in place, signed agreements have been uploaded and quotes align with budgeted amounts in HCC Life
  • Act as an audit agent in Ariba, ensure correct GL codes are used and correct information is input into Ariba.
  • Review PO reports from Procurement to ensure that HCC related PO’s have been raised correctly.
  • Ensure that the correct method of payment is used. No batch payments or request for payments to take place unless prior approval from HCCO
  • Running monthly dashboard reports to identify if any relationships are up for Mid Term or renewal in the next three months and proactively connect with the business sponsor to agree on next steps.
  • Completing reputational checks via Factiva for the principals / board members at the TPI and working with the Business Sponsor to clear all hits and get the files ready for upload.
  • Audits: Complete and support all actions of any audit assigned to TPI Oversight Person

Trade Compliance Lead

Johnson and Johnson
05.2021 - Current
  • Overall import & export process control: documents check, customs clearance monitoring, shipments tracking, communication with customs brokers and customs authorities.
  • Export day to day Operations lead; coordinating activities across Customer Service, Planning, Warehouse, and Commercial leader.
  • Responsible for providing and managing Export KPI's and reporting/ governing OTIF above target.
  • Clearing instruction (for each shipment) filling, signing, and providing to customs clearance agents (authorized person by J&J with sufficient customs knowledge acknowledgement) + clearing instructions for VOC (voucher of correction).
  • Interaction with goods suppliers and forwarders in the context of shipment dates and shipping documents: control and approval.
  • Ensuring the timely process of customs clearance of goods of the company and the release for free circulation.
  • Implementation and maintenance of customs clearance/trade compliance KPI Dashboard in alignment with 3PL.
  • Maintaining a product database (product library), necessary for customs clearance, its updating and storage.
  • Master Data support (if required).
  • Ensuring the safety of cargo documentation in electronic form.
  • Recordkeeping process establishing and maintaining.
  • Customs broker management implementation (SLA, KPI contracts, invoices control).
  • Regular operational meetings with CCA (QBR).
  • Trade Compliance DRI for EMEA Trade Compliance team. Working closely with RTC on the Global Trade Compliance Standards deployment (SOP creation, control implementation, issues escalation, post entry review process, CIA audit preparation).
  • Development, implementation and update of SOPs and process flows.
  • External legal providers management upon needs.
  • Advising/ informing business representatives on customs clearance issues.
  • Customs agents portfolio optimization.
  • Special customs procedures arrangement (for ex. Inward/outward processing, temporary import, and temporary import via carnet ATA): understanding of requirements and possible risks, discussion with customs broker and communication to Business Units.
  • Customs legislation changes monitoring.
  • Identifying improvement areas in import & export processes.
  • Communicate in all directions to keep associates, peers, and Management informed of project status, process changes, and opportunities.
  • Respond to global shipping network changes and drive all required changes from a Trade Compliance perspective.
  • Preparation and optimization of customs clearance processes of Medical Devices products
  • Submit monthly performance metrics for business portfolio to Senior Manager, analyse and provide insight on issues, challenges, and potential corrective actions.
  • Finance and SARS
  • Lead SARS and participant government authorities' management discussions (requests, audits management); report to all key stakeholders as required.
  • Xfunction collaboration (finance, legal, tax, RA, etc.)
  • Budget control (customs payments and brokerage fee); drive cost reductions where applicable in accordance with regional targets
  • Project Management:
  • Lead departmental/divisional projects, participate on company task forces as assigned.
  • Use continuous improvement and lean tools and methodology to evaluate, challenge and optimize business processes.
  • Utilize analytics and drive toward data driven decision outcomes.
  • Identifies, analyses, and develops solutions for a wide variety of problems and issues that drive measurable improvement.
  • Other duties as assigned.
  • Support to strategic internal projects of the company.

Quality Specialist

Johnson and Johnson
01.2019 - 04.2021
  • Distribution and Inventory Management Processes
  • Responsible for execution and overseeing the controls and quality standards for all distribution and inventory management activities at designated DC’s (e.g., receiving, pick, pack, lot reconciliation)
  • Responsible for robust product disposition procedures and the quality oversight of all product quality holds and field actions impacting their designated Distribution Centers.
  • Responsible for evaluating the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations.
  • Quality Management Systems
  • Responsible for ensuring the appropriate handling of distribution related customer complaints including track and trend and mitigation of Quality related issues.
  • Responsible for management of Quality systems, including CAPA process and systems, document management, change control, training management, preventative maintenance systems, Quality agreements, other.
  • Special Processes (Product Testing, Repack-Relabel, Temp. Control & Monitoring)
  • Responsible to provide support in the implementing of requirements for repackaging and relabelling operations to be conducted within their designated Distribution Centre to assess repackaging and relabelling requests and collaborate with business partners to meet pre-defined requirements.
  • Responsible for Quality management of repacking, relabelling, over labelling, kitting, and reworking operations conducted within their designated DC
  • Responsible for validation of temperature controlled (cold chain and controlled ambient) facilities with support and directions from the Sr. Manager Transportation and Temperature Control Q&C, CLS Q&C EMEA.
  • Responsible for accurate and timely communication of temperature control excursions occurring within their designated DC to appropriate partner.
  • Responsible for the investigation of temperature control excursions and subsequent remediation activities.
  • Managing Quality and compliance of Two DC’s (Ensuring regulatory (ISO9001, ISO 17025 and SAPRA) standards are always met).
  • Ensuring Both Sites are licensed and approved by the required authority bodies and approved for distributional purpose of Medical Devices.
  • Managing Qualification and Training compliance for the local business (ensure Training matrix are up to date and training material is always relevant for performed activities).
  • Perform Internal audits to ensure compliance of the sites.
  • Manage Quality related suppliers to ensure they provide the required service to the business (develop and review SLA, Quality agreements for the suppliers).
  • Investigate Non-conformances and manage change controls for both sites.
  • Manage QMS activities for the business (Document managements system, training system GCC and NC system).
  • Compliance
  • Responsible for preparation of and remediation of actions stemming from Health Authority inspections (e.g., FDA, MHRA, etc.) as well as other logistics and transportation related inspections (e.g., TSA, DEA, etc.) conducted.
  • Responsible for the proactive identification and mitigation of compliance risk at the DCs through QScan, internal audits, and other compliance programs.
  • Distribution Supplier Quality Management
  • Responsible for actively providing Quality input and oversight on distribution network changes.
  • Always act with CREDO values in mind
  • Reason for wanting to leave: Appointed to a new position.

Plant Quality Co-ordinator and Packaging Technician

Johnson and Johnson
05.2016 - 12.2018
  • Investigate and Support production department on all packaging issues rising.
  • Manage Quality and compliance of all packaging suppliers and supplier qualification.
  • Support validation and new product development project for all the developed SKU.
  • Investigate complaints and counter fit issue that might rise to ensure business security and integrity.
  • Support in packaging development and design to ensure innovation for business.
  • Conduct product testing and release for cosmetics products.
  • Reason for wanting to leave: Appointed to a new position.

Inprocess Quality Controller and Mixing Operator

Johnson and Johnson
11.2009 - 04.2016
  • Mix and develop cosmetics and pharmaceutical products for the business.
  • Perform all necessary tests and chemical adjustments to ensure all product meet the required specification and standard.
  • Perform lines clearances and line closure to ensure compliance during manufacturing process.
  • Perform in process Quality check to ensure production compliance.
  • Review and calculate production yield for all production lines produced during the shift.
  • Reason for wanting to leave: Appointed to a new position.

Education

BCom Honours - Supply Chain Management

MANCOSA

Advanced Diploma - Finance Management

Regent Business School
01.2025

Diploma - Chemical Engineering

Mangosuthu University
01.2023

Certificate Lead Auditor - undefined

BSI Training Academy
01.2022

Higher Certificate - Total Quality Management

UNISA
01.2021

Diploma - Packaging Technology

Institute of Packaging SA
01.2018

National Certificate - Product Technology

PMI
01.2013

Certificate Intro - Project Management

INTEC College
01.2011

Skills

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Internet Explorer

Teams

Zoom

Investigation techniques

Compliance monitoring

Reporting skills

References

  • B, Gqongwana, Mixing and Filling Supervisor, bgqongwa@kenvue.com, 081 565 7740, Johnson and Johnson Consumer
  • Johannes, Tlakula, Warehouse Manager, jtlakula@its.jnj.com, 083378 7339, Johnson and Johnson Medical
  • Prosper, Nyakudiga, Country Finance Lead, pnyakudi@its.jnj.com, 072 849 3107, Johnson and Johnson Medical
  • Thando, Shabalala, QA Specialist/Warehouse Team Lead, tshabalala@its.jnj.com, 071 850 6598, Johnson and Johnson

Timeline

Business and Statutory Compliance Specialist

Johnson and Johnson
01.2023 - Current

Trade Compliance Lead

Johnson and Johnson
05.2021 - Current

Quality Specialist

Johnson and Johnson
01.2019 - 04.2021

Plant Quality Co-ordinator and Packaging Technician

Johnson and Johnson
05.2016 - 12.2018

Inprocess Quality Controller and Mixing Operator

Johnson and Johnson
11.2009 - 04.2016

Advanced Diploma - Finance Management

Regent Business School

Diploma - Chemical Engineering

Mangosuthu University

Certificate Lead Auditor - undefined

BSI Training Academy

Higher Certificate - Total Quality Management

UNISA

Diploma - Packaging Technology

Institute of Packaging SA

National Certificate - Product Technology

PMI

Certificate Intro - Project Management

INTEC College

BCom Honours - Supply Chain Management

MANCOSA
SIVENATHI SIKAMBULEBusiness And Statutory Compliance Specialist