Assistant Manager, Quality Assurance at Teva Pharmaceuticals

Your responsibilities

As an Assistant Manager, Quality Assurance you will support the Commercial Quality department to ensure compliance and contribute to the company meeting its quality and regulatory objectives.

In this role, you will...

Perform timely product release to the market

• Review release documentation and ensure compliance with dossier and South African/African regulations
• Review and assess the temperature data for the shipment in accordance with the product storage conditions
• Ensure release of products according to South African regulations
• Manage schedule register (S5 and S6)

Ensure products imported to South Africa are in accordance with Local Regulations and Teva Quality standards

• Roll out of Teva Quality Management System in South African market
• Track, review, assess and approve change controls, deviations, complaints and CAPA’s
• Assess all deviations that could influence the quality of the batch and define related CAPA’s
• Lead and compile investigations if required as well as assist other teams with investigations
• Support investigations, contact manufacturer and client answering of complaints
• Management of import permits
• Compile, review and approve SOPs as per Teva quality standards
• Manage the Returns process with the warehouse

Provide Quality oversight of third party suppliers (PQRs, Vendor qualification, QTAs) 

• Ensure that PQRs are completed as per schedule
• Ensure that CMOs are qualified and regularly audited by Teva by liaising with Teva Global audits team 
• Ensure that QTAs are in place for local CMOs and that Appendices to global QTAs are correct and completed timeously by working with Teva Global QTA team

Act as a back-up to the Senior QA Manager

• Contact with local health authorities in relation to GMP/GDP inspections, quality incidents and recalls
• Responsible for quality oversight and regularity compliance of product marketed in South Africa
• Roll out of Teva Quality Management System at commercial unit level (including local warehouse, if applicable)
• Ensure operational implementation of QMS in compliance with GMP/GDP and Teva Corporate and Regional growth markets standards
• Take the lead during internal audits and audits from HA authorities and global QA

Responsible for the quality of product distributed in Africa  

• Roll out of Teva Quality Management System in Africa
• Review and assess temperature excursions experienced and provide product disposition
• Assist Teva Africa team with all Quality concerns

Report any critical quality incident to the International Quality and local Management team (with corresponding corrective action plan if necessary)

• Notification to management in a timeous manner and as per procedures
• Lead investigations, provide and implement corresponding corrective action plan

Your profile

• Bachelor of Pharmacy degree
• Min 3 – 4 years experience working in a manufacturing and/packaging facility
• Min 3 years Quality Assurance experince as an MA Holder
• Min 1-2 years experience working with African countries
• Experience with managing and implementing QMS
• Demonstrated knowledge and working experience with PIC/S GMP and GDP and government regulations for South Africa
• Knowledge of the pharmaceutical industry (MA Holder within a factory setting) 
• Knowledge of pharmaceutical import and distribution operations
• Ability to clearly communicate with all levels in the organization including Health Authorities 
• Ability to communicate effectively with Teva Suppliers and Vendors
• Independent with an ability to solve complex quality topics 
• Demonstrated experience in supplier audit management and hosting regulatory audits  
• Exellent collaboration and  multi-stakeholder management skills
• Ability to problem-solve and make high level decisions 
• Ability to act as second in charge in absence of QA Manager (ncluding ability to communicate to management levels)
• Ability to work under minimal supervision 
• Ability to lead processes, projects and people
• Proficient computer skills in current software including MS Office and Excel
• Oral and written fluency in English

Willingnes to travel (mainly domestic) based on business needs