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Quality Systems Improvement Project Associate - Belgium
Keyrus Biopharma (company)
Posted on : 15 April 2017
We are looking for an experienced Quality Systems Improvement Program Associate for one of our clients.
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
Our company is a European full-service Contract research organization (CRO) providing biopharmaceutical, nutritional, cosmetic, animal health and medical device industries with a broad range of clinical research services from early- to late-stage clinical development, including project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance, regulatory affairs, and medical writing.