Quality Assurance Manager at Roche

Job description

Roche Diagnostics South Africa is seeking a Quality Assurance Manager (Domestic and Export Markets) in Midrand, Johannesburg to manage Quality Assurance and QMS within the supply chain management process for in the SADC region and for drop shipments to the export markets, to ensure product safety, quality and performance, and ensure continuous improvement in line with relevant ISO standards.

Quality Assurance (QA) Management

• Ensure that the Quality Management System is implemented, maintained and updated to sustain the company’s international and national QMS certification; ensure all local stakeholders are updated and trained on QMS requirements, best practice and SOPs and any amendments thereto.
• Overall responsible for maintenance of the company quality management and ISO certification, audit of internal processes and quality issues for the export countries; responsible for adoption, training, and implementation of local processes in accordance to the applicable divisional standards.
• Lead the compliance implementation and management of the QMS to ensure product release requirements meet product safety, quality and performance efficacy requirements within the Supply Chain management process.
• Interact on daily basis with the Operations department in all quality related matters.
• Identify and provide advice and solutions to address QMS problems.
• Update QMS policies and procedures in accordance with certification requirements or continuous improvement strategies.
• Plan for and conduct regular QA compliance audits on the Roche warehouse and third party logistics providers and export distributors and make and ensure implementation of approved recommendations for QMS improvements.
• Monitor and assess Key Performance Indicators (KPIs) as defined by Global Quality & Regulatory structures, and ensure that local management reviews as required are carried out together with the Head of Department.
• Serve as the deputy Local Safety Officer (LSO) in the absence of the Head LSO.

Complaints Management

• Responsible for the supervision, monitoring and improvements for handling local inquiries and complaints and escalating all PCC (potential critical complaints) to Regional Safety Officer and manage and administer the local Product Complaint Management software and updating of the Safety information on Agency SharePoint.
• Record and load complaints on the CRM system in respect of product quality, safety and performance from all customers falling within the supply chain and address these complaints timeously.

Self Management

• Identify areas for continuous improvement and implement agreed improvements in areas of responsibility and remain up to date with SOPs regarding functional requirements within Roche local or global or on an industry level if applicable.
• You, as an ideal candidate, will have the following skills, experience and education:
• Required Qualification: Medical / Science Degree essential (pharmacy preferable) or related qualification. An Honours degree is preferable.
• Required Experience: A minimum of 5 years of Quality Assurance and Management experience in a pharmaceutical or diagnostics environment is required.