Manager Quality Assurance - France
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Posted on : 14 May 2017
- We are currently looking for a Quality Assurance Manager to lead our QA team.
- Our company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription (Rx) pharmaceuticals and nutritional products.
- The company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market and an industry leader in pharmaceutical technologies
- Our company has a wide brand portfolio including top brands. This portfolio has been expanded with international brands.
- Our Company has managed to build a high-performance, customer-focused organization which today is directly operating in 35 countries – mainly in Europe - serving a high potential market of prescription-free, consumer-oriented health products, with different legal status ranging from medicines, medical devices, cosmetics, food supplements and biocides.
- Within the framework of the Quality Policy of the company, the QA Manager is responsible for setting up an efficient Quality Management System (QMS) compliant with the current regulations that guarantees that medicines and medical devices meet the quality requirements for their usage.
- The QA Manager acts within the company’s status of Operator of the Marketing Authorization Holder (“Site Exploitant”).
- Management of the Quality Management System and control of quality related documents (procedures and regulations conformity) , support to users
- Management of certified auditor’s audit in order to maintain the certification of the company , and management with the company’s Pharmacist of the inspections from health authorities
- Represents the management of the company towards people or internal and external organization concerned by the quality system and certification
- Management of internal and external quality audits in cooperation with the regulatory team
- Conduct internal and external audits
- Internal training on quality and materiovigilance
- Management on Management Reviews in order to inform the General Management on the Quality Management System operating
- Participate in the design of suppliers and sub-contractors RFP specification, follow up of suppliers and sub-contractors
- Participate in the evolution of the company’s QMS and propose solutions to improve products and services quality
- Manages of a team two QA specialists
- Minimum of 5 - 10 years’ experience within QA
- Ability to manager relationships with external stakeholders such as Certified Quality Auditors, sub contractors and suppliers, Health authorities
- Master level education in Science (Chemical, biochemical etc…) and Quality Management
- Good knowledge of the French regulatory environment Medicines, Medical Devices, Quality: NF EN ISO 9001/ NF EN ISO 13485 / BPF /BPD / Directives 93/42/CEE et 98/79/CEE
- Fluent in English AND French
- Experienced in auditing