Wilbur van Wyk

I am an experienced individual who pays attention to detail. My purpose is to uplift & progress myself, people & systems.

Was part of production of Medical devices & clean environments.

Regulatory, Standards, Quality control & Assurance is my background

Consultant at Freelance (2023-11 – Present)

• I am currently a Consultant to SME's, assisting in establishing Good Manufacturing Processes (GMP) and document their operations – create Standard Operating Procedures (SOP) in compliance with local, regional and International Standards.
• Train staff to use documents, follow SOP's and record all activities as a means to verify compliance to International standard requirements.
• Train on-site auditors to monitor internal operations.

Warehouse Manager, Product Control & Training Officer at Sam's Cash and Carry CC (2023-09 – 2023-11)

• I was part of responsible for training staff on Company Policies, Procedures & setting up processes in conformance with regulations, organising the warehouse.
• Setting up Company Documentation – Standard Operating Procedures, Site Master Files, Risk & Environmental Management Files, Product Handling, storage and Movement.

MD/Operations Manager at WGD Trading Namibia CC (2021-01 – 2023-09)

• I started my own apparels company and employed 7 workers.
• Cut, stitch & trim factory producing sportswear, school wear and corporate wear (printing, embroidery).

Group Quality Manager at Doré Pharmaceuticals (Pty) Ltd / Commodity Exchange CC (2014-01 – 2020-04)

• I was part of Research team to develop documents for building, Control, Maintenance plus design required SOP's (standard Operating Procedures), Policies & Technology.
• Liaise/Engage with Suppliers, Industry Leaders & Pharmaceutical Leaders, Training received in New Ulm, Germany with Uhlmann Germany to operate Blister Units (tablet packing) for Production & packaging of Pharmaceutical tablets.
• Designed Class D cleanroom for production of API's (Active Pharmaceutical Ingredients) – essential medicines such as Paracetamol, Ibuprofen, Metformin, Azytromycin and Perindopril.
• Designed Laboratory to Conduct In-process testing, SOP's, Certificate of Analysis development, Post Production testing requirements, Customer Satisfaction Surveys, Product Recall Process development, Staff Training programs and schedules
• Design & Develop (JIT) Just-in Time Production programs & schedules.
• Continuous Review of system operation in compliance with European Union Current Good Manufacturing Practices (EU cGMP) requirements.
• Received training on the operations of BEC 300 – Blister unit – Production of solid dose (medicinal tablets) Environmental Controls, Design, Develop and Build Class D – cleanroom for production of medical devices.
• Trained with PECB Canada to become Assessor & lead Auditor – ISO 9001, 13485, 4074, 17025 and other related standards.
• Assisted GIPF fund recipient to Develop System SOP's, Relevant Compliance Documentation, train staff on international & local standards and Company Policies developed, Compliance Monitoring, Risk Management training of local SME's who was funded to upgrade their operations.

Production Manager/ Assistant Laboratory Engineer and Warehouse Manager at Doré Pharmaceuticals (Pty) Ltd / Commodity Exchange CC (2006-01 – 2025-04)

• I managed the processing, testing, packaging and distribution of the "SMILE" Male Latex Condomes - Downstream Production Process.
• ISO / SANS 4074 Quality Control Laboratory Testing of male latex condoms.
• Responsible for machinery for testing and validations.
• Annual calibration and servicing of equipment.
• Annual Training program – ISO standard amendments/changes – new operation procedures, work instructions. Policies, Objectives, Technical Reports/ files.
• Draft and Implement Required standard operations policies and objectives. Control all operations through continuous monitoring & evaluation of Processes.
• Control all Documented information relevant to operations through records, reports and Production output results.
• I served in various cross-functional roles, where my other duties also included – Training Officer / Internal Auditor / Management Representative / Logistics Management / Assistant Laboratory Engineer.

Machine Minder at John Meinert Printing (Pty) Ltd (2003-01 – 2006-12)

• Qualified Printing Minder;
• Operator of A Heidelberg 4 Colour Press;
• Printing books, annual reports, financial reports, leaflets, promotional banners;
• Cylinder operator (embossing, dye cutting, form creation);
• Leather book binding;
• Operating multi head folding machine for school curriculum books.

Machine Minder at Printech (Pty) Ltd (2003-01 – 2006-12)

• Printing assistant to Printing minder;
• Ensure availability of printing materials;
• Collection of paper and ink from the storeroom, ensure correct storage;
• Ensure Printing Minder has job cards on hand;
• Place/stack and remove before and after printing production;
• Ensure cleanliness and safety of the machine;
• Assist with maintenance of the press.

Diploma in Total Quality Management – University of South Africa (2018-01 – 2019-12)

Diploma in Total Quality Management – Damelin Business School (1999-01 – 1999-12)