SIRE Life Sciences®
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SIRE® 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 organisation, based in Netherlands.
The CompanyThe company is at an very exciting phase, with a lot of expansion within Europe
Role DescriptionIn this very exciting role you will become responsible for a very exciting phase within the company. Your 2 major responsibilities will consist out of developing in-country Quality Management Systems as a sub part of the Global Quality Management System.
Also, you will require license infrastructures to enable local commercial operations.
You will be traveling up to 30% to make sure that the sites are on track.
Responsibilities-You will be part of a team which will develop a quality assurance program in Europe. This means you will get an active role within training and audits, you
will require and maintain licences for distribution within Europe.
-You will review SOPS, investigations, specifications, validation reports, manufacturing records and analytical reports
-Provide quality oversight, which includes performing audits and establishing quality agreements with our service providers
-You will be overseeing product issues in Europe, including recalls and complaints
-Establishing an efficient workflow to ensure operational excellence, while making sure that all quality operations are in compliance throughout a QMS
-Prepare, review and approve reports both internally and externally required by regulatory agencies and customers
-Provide training and support to staff members to develop auditing resources
-Lead in operational in excellence initiatives companywide, in order to obtain overall improvement
-Collaborate with other departments to increase the effectiveness of the quality department
-Audit facilities of vendors and outside contract organizations
-Play an active role in obtaining and maintaining any required pharmaceutical licences for marketing products in Europe
-Apply Risk Management where required.
-Assist in other quality assurance related activities as agreed with management.
-Assist in supporting Health Authority Inspections/Audits at Licensed Sites
-Electronic management of local QMS documents and records
-Assist in oversight of external QP/RPs to ensure compliant product release.
RequirementsExperience in launch processes of new products.
At least 8, but preferably 10 years of QA experience in regulated industry such as pharmaceutical or biologis, preferably in a position with similar responsibilities.
Experience with effectively managing regulatory agency inspections, working with regulators, and vendor/supplier audits.
Broad knowledge of risk-based quality systems approaches
• Master degree in Pharmacy, Chemistry, Life Science or related discipline.
• Full understanding of GDP and GMP.
• Understanding of medical device regulations.
• Understanding of EU inspection procedures.
• Must have excellent communication skills (verbal and written).
• Fluency in English
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.