Amka Consulting (Pty) Ltd is focused on building capability in the supply chain environment with a suite of offerings, ranging from Operations Excellence to Total Quality Management. Amka’s intention is not only to build capability in management systems but also optimize team performance and leadership behaviours and skills.

Director at Khelp Associates that is a BBB-EE Level 2 accredited consulting company that specialises (amongst others) in Workplace Organisation/Shop Floor Design, Problem Solving/Improvement in Quality, Manufacturing and Packing, and Operationalisation of New Facilities.

Managed and Coordinated On-Site Regulatory Authority Quality Inspections for relevant Manufacturing Facilities.Liaised with local & international Regulatory Authorities & Affiliates with regard to timelines for launches incorporating submission, validation and approval timelines.Facilitated CAPA (corrective action preventative action) Plans, Approvals & company Communication with Regulatory Authorities.Provided the role of QA Oversight and Approval of MES (Pas-X) Implementation and Validation documentation for Aspen Port Elizabeth Site. Manufacturing execution systems (MES) are computerized systems used in manufacturing to track and document the transformation of raw materials to finished goods.

As per SAHPRA (South African Health Regulatory Authority) and SAPC (South African Pharmacy Council) Regulatory Requirements and Procedures in place. Role ran concurrent with other roles within the company.

Managed the Quality Assurance Department in terms of Key Performance Indicators and Staff Outputs.Maintained an effective Quality Management System to support interface matters and ensure compliance with current GMP.Managed and executed the Batch Release process.Managed On-site Regulatory and Third Party Audits.Facilitated CAPA plans and Approvals.Coordinated and Managed Regulatory Audits.Liaised with Regulatory Authorities and Affiliates in terms of Specific Requirements for each Regulatory Authority.

Maintained an effective Quality Management System to support interface matters and ensure compliance with current GMP.Quality Systems included the management of Deviations, Change Controls, Customer Complaints, CAPAs, Vendor Management, etc.Established systems for the management of international sourcing and supply of products.Ensured Technical Agreements were in place with Contract Manufacturers; Monitored compliance with Good Manufacturing Practice of Contract Manufacturers (local and international).Managed and ensured execution of the batch release process.Lead the Outsource Quality Department.Provided timeous and periodic management review reports