Over deze baan
- Branche: Pharmacie
- Expertisegebied: Veiligheid
- Standplaats: Utrecht
- Uren per week: 40
- Opleidingsniveau: WO Bachelor
- Sluitingsdatum: zaterdag 27 maart 2021
For our international pharmaceutical customer we are looking for the Technical Expert QC Operations – COVID-19 Release & Stability support to join the team.
Are you looking for the new challenge within one of the industry top players? Then we are looking forward to receiving your application!
- Build & Maintenance of DS & DP Specifications and Stability studies & Work items to support Stability testing
- Maintain CBER automated reports
- Build & Maintenance of Workitems, Super sample templates to support IPC’s and release testing
- Support Eurofins with Stability study executions (cfr Stability coordinator role in stab labs)
- eLIMS SKU (Site Key User) role for Eurofins: Update of eLIMS EXT roles stability Access & Securities, SOP’s, training, User Access Management, level 1 & 2 support
- eLIMS Project Management - meetings, planning, documentation (SOP’s, CC’s, …)
- Bachelor's degree or equivalent education
- 4+ years of working experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) with knowledge and experience with LIMS and Quality system is required.
- Broad knowledge and experience with cGMPs, applicable regulations (e.g., FDA, ICH Q8, 9, 10), and risk management.
- Experience in Master Data Management
- Detail oriented, accurate way of working
- Fluent English
- Up to 5% Travel required
- Work from home possible
Brunel offers outstanding individuals a highly diverse and challenging job opportunity in a company where an open, professional and pleasant working culture is greatly valued; where your personal initiatives will be noticed and rewarded; and where you will receive all the support, coaching and training you need for your future career. This is your opportunity to discover a wide range of sectors and activities and develop your expertise in a fast-moving and results-oriented environment. Being intermediated by Brunel means that you are contracted by Brunel. Not only you will have a contract, you will as well be assured of a great career! Our primary and secondary terms of work are excellent. A few examples are price reductions at CZ Health Insurance, bonus opportunities and standard 26 days off. Brunel Engineering intermediates both junior and senior engineers within the industry for over 30 years now. Our clients vary from multinationals to local companies. Together we will find the job which meets your wishes.
Sluit je aan bij de Brunel Community
Brunel is an international organization which can offer work on exciting and challenging projects in collaboration with our partners within various industries. These sectors offer opportunities to participate on the development of new technologies amongst world class organizations. Our industrial partners seek the best professionals who possess the ambition and enthusiasm to excel. Brunel is an international provider of services specialized in project management, secondment and consultancy in the disciplines of Engineering, IT, Finance, Legal, Marketing & Communication, Healthcare and also all disciplines in the oil & gas industry. Since its establishment in 1975 Brunel developed itself in an international organization with over 11.000 employees. Brunel Engineering is specialized in secondment of technical specialist with a Bachelor’s, Master’s or Ph.D. in all technical fields. The sectors in which Brunel Engineering is active are High-tech, Production, Construction, Infrastructure and Industry. Brunel is also dedicated to the personal development of its employees and supplies them with an extensive training program.
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