The mission is essentially focused on technical writing of documentation related to stability studies managed by the team (protocols, report). Therefore the main responsibilities will be:
- Preparing/reviewing stability or comparability protocols
- Analysing results
- Verifying data
- Validating results within Lims system
- Preparing/reviewing stability or comparability reports and certificate of analyses
- Following deviations and incidents
- Preparing/reviewing specification and associated justification of specifications
- Ad hoc presenting/discussing results in project team meetings.
All these activities will be performed in compliance with the GMP/HSE rules and with the regulatory requirements for each development phase of the product.
- Master’s degree, in biochemistry or in analytical chemistry
- A first similar experience preferably in the biotech industry
- Good knowledge of English and ability to read/write GMP documents (2-3 years of experience in writing GMP documents, previous experience in stability is a plus)
- Good knowledge in analytical techniques applied to proteins, such as: chromatography or electrophoresis (gel, capillary), immunoassays, q-PCR or pharmacopeias
- Basic knowledge of statistics applied to stability or comparability studies
- A good knowledge of GMP standards in QC laboratory
- Good interpersonal, verbal, and written communication skills with ability to balance multiple priorities
- Well organized, flexible, meticulous and rigorous, proactive, with a strong team spirit
- Able to work in a multicultural environment
What we offer
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park Waterloo - Drève Richelle 161 - 1410 Waterloo
- Nijverheidslaan 3, - Strombeek-Bever