Quality Assurance Manager

Quality Assurance Manager
Company:

(Confidential)


Quality Assurance Manager

Details of the offer

Job Description A global pharmaceutical company is seeking a QA Manager to be responsible for the maintenance of the SAQ management system as part of the EAME and supply chain quality system while ensuring local required systems are fully functional and in place, compliance with relevant GxPs, ISO 13485 and relevant local legislation Requirements: Minimum of 5 years? experience in quality related of production in the pharmaceutical | medical industry 3+ years tertiary education in the medical | scientific field (B.Pharm | QA Diploma) Supply chain quality management | Project management and technical reporting experience essential Experience with ISO standards and GMP quality systems required in the pharmaceutical| medical device industry Enthusiasm and quality improvement orientation Previous senior level administration experience essential (preferably in a pharmaceutical company) in MS Word | Excel | Powerpoint Proficiency on QMS and Coral and a willingness to learn additional packages as necessary Excellent verbal and written communication skills Ability to respond to urgent requests timeously Ability to adhere to agreed performance standard Self-driven and motivated | able to prioritise and resolve competing priorities Responsibilities: Developing Developing quality management systems and overseeing all GxP functions for both Pharmaceutical Products and Medical devices Raising the profile of QA related issues to business Ensuring SOP? s | API EAME regional SOP? s and Corporate Standards, Policies and Procedures are aligned through reviews and updates During recall situations acting as South African QA contact LMS administration and local training support for the QA function Ensuring all 3PL? s maintain SOP? s within the quality systems that meet requirements of the company? s Quality Standard, Policies and Procedures Internal auditing of South African office and local vendors | distributors to evaluate compliance while providing a non-conformance report to Management | the Supply Chain QA Manager | Allergen GxP Departments | 3PL? s | distributors and suppliers Supporting the local Quality & MAH requirements Establishing a Change Control and Risk Assessment system within South Africa and supporting the Change Control and Risk Assessment system within API supply chain and EAME region Supporting transport and distribution compliance relating to the storage | packaging | over labelling and distribution of products and legal | regulatory requirements Controlling RSA documentation for document management system and locally required QA SOP? s Managing the Quality Improvements Initiative through Quality facilitating | Regional quality management reviews | Acting as QA Representative for the region on supply chain expansion and compliance reports | Ensuring QMS is consistent in the region | Developing the temperature control distribution requirements in RSA and related markets

Requirements


Knowledges:

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