CMO Quality Management
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Utrecht Netherlands.
· QA lead on executing supply mitigation strategies (excess stock purchases, second/third supply sources and related activities)
· QA lead to ensure proper and timely evaluations of supplier change notices.
· Partnering with GMP Compliance and Supply Chain, develop QA risk strategies for key suppliers.
· Responsible for ensuring the execution of developed risk strategy.
· Direct liaison for the Quality Agreements for responsible suppliers
· Direct liaison for issue resolution, which may include deviation review at supplier, and internal deviation writing/investigation, and associated CAPAs.
· QA lead on the review of annual material qualifications and related testing for excipients and APIs.
· Audit facilities of key suppliers, follow-up on implementation of supplier CAPA plans
· Assist in other quality assurance related activities as agreed with management.
· At least 10 years of QA experience in regulated industry such as pharmaceutical, or biopharmaceutical, preferably in a position with similar responsibilities.
· Experience with vendor/supplier audits.
· Experience with external vendor management and proven ability to influence.
· Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals.
· Minimum MS degree in Pharmacy, Chemistry, Life Science or related discipline.
· Full understanding of GMP.
· Must have excellent communication skills (verbal and written).
· Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
· Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Seppe Verhoeven
The Company
Our client is a professional pharmaceutical organisation who produces medicines in het USA. At the moment they are expanding to Europe with their head office near Utrecht station.Role Description
Provide Quality Oversight of suppliers of commercial process starting materials including but not limited to excipients, APIs, and primary packaging components.Responsibilities
· Direct QA liaison for key suppliers for raw materials including excipients, APIs, and primary packaging components.· QA lead on executing supply mitigation strategies (excess stock purchases, second/third supply sources and related activities)
· QA lead to ensure proper and timely evaluations of supplier change notices.
· Partnering with GMP Compliance and Supply Chain, develop QA risk strategies for key suppliers.
· Responsible for ensuring the execution of developed risk strategy.
· Direct liaison for the Quality Agreements for responsible suppliers
· Direct liaison for issue resolution, which may include deviation review at supplier, and internal deviation writing/investigation, and associated CAPAs.
· QA lead on the review of annual material qualifications and related testing for excipients and APIs.
· Audit facilities of key suppliers, follow-up on implementation of supplier CAPA plans
· Assist in other quality assurance related activities as agreed with management.
Requirements
· Familiarity with Quality Assurance aspects in launch processes of new products.· At least 10 years of QA experience in regulated industry such as pharmaceutical, or biopharmaceutical, preferably in a position with similar responsibilities.
· Experience with vendor/supplier audits.
· Experience with external vendor management and proven ability to influence.
· Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals.
· Minimum MS degree in Pharmacy, Chemistry, Life Science or related discipline.
· Full understanding of GMP.
· Must have excellent communication skills (verbal and written).
· Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
· Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Seppe Verhoeven
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
