Quality Systems Improvement Program Poject Associate - Belgium
Keyrus Biopharma (company)
We are looking for an experienced Quality SIP Project Associate.
Role and main tasks:
The candidate will :
- Implement the Global Quality Manual in one of the company's site
- Compare the site's practices with the updated global guidelines:
- Establish gaps - make an implementation plan per segment, with deadlines for making modifications and process adaptations
- Establish matches - update site Quality Manual if needed
- Follow-up with managers and global experts to fix gaps for further implementation
- Maintain deadlines and extend them in certain cases, which ask more time implement the new way of working
- Investigate the impact of modifications on the organization
- Give trainings internally on the new way of working
- Have contact with global experts regularly (WebEx based)
- Scientific background
- Wide experience in and passion for quality management systems is a must
- Good knowledge of GMP (Good Manufacturing Practices)
- ideally, at least 3 years in the pharmaceutical industry
- Mature and decisive personality
- Good organizational skills
- Fluent in Dutch and English
- Will travel once in a while to others plants in Europe to follow joint training on new requirements, but flexible timings and respect for work/life balance
What we offer
You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who we are
Keyrus Biopharma 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 Biopharma 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:
- Chée de Louvain 88 - Waterloo-Lasne
- Rue Emile Francqui, 1 - Mont-Saint-Guibert
- Nijverheidslaan 3, - Strombeeck Bever