Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld.
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CMO QA Manager
Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company
Het bedrijf / The company
A vertically integrated business, economies of scale and an extremely skilled team enable them to deliver quality products in a timely manner at affordable prices. It provides high quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma's global presence is supported by 47 manufacturing facilities spread across six continents, R&D centers across the globe and a multi-cultural workforce (30.000) comprising over 50 nationalities. The consolidated revenues for 12 months ending March 2016 are approximately US $4.3 billion. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of over 8% of annual revenues.
The European head office (WEU) is based in Hoofddorp, The Netherlands
De functie / The role
The CMO QA Manager is responsible for managing quality aspects at external Contract Manufacturing Organizations for Sun Pharma Products for the EU market. Ensure that the operational business at Contract Manufacturing Organizations is in compliance with Current Good Manufacturing Practice, with the Quality Assurance Agreement, regulatory requirements and the Sun Pharma Standards. Ensure that activities at Contract Manufacturing Organizations are conducted according to the relevant Standard Operating Procedures. Active participation in Product Acquisitions and technology transfer X functional projects.
Het profiel / Your profile
Bachelor degree or higher in Pharmacy, Biology, Biochemistry, Virology, Microbiology or another related science.
o 8 or more years" experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products.
o Experience in Quality Assurance Operations, production, Quality Control and/or other relevant operational areas, but must include minimally 5 years in Quality Assurance, and 3 years of management and or project management experience. Experience in combination products is a plus. Experience as QP is an asset.
o Thorough knowledge of Current Good Manufacturing Practice requirements.
o Strong understanding of regulatory requirements for commercial products.
o Proven track record with Food & Drug Administration, European Medicines Evaluation Agency and other Health Authorities.
o Strong understanding of risk assessment and risk management fundamentals/tools.
o Strong Technical understanding of (bio) pharmaceutical processes.
o Ability to effectively manage multiple, complex priorities.
o Team and consensus builder, with definitive and authoritative decision making ability.
o Fluent in speaking / writing in English.
Het aanbod / The offer
The salary is competitive and appropriate for the seniority of the position, including an attractive bonus, pension plan etc.