Validation coordination – R&D Equipment and Projects - Belgium
Role and main tasks:
- In the context of projects/equipment's investments (new or upgrades) in product production, ensure proper execution of the appropriate methodology and application of cGMP (Validation Master Plan, Design Qualification, Commissioning, Installation & Operational Qualification and Validation Reports).
- Management of the Validation documentation and its archiving : writing, reviewing, approving.
- Ensure that all GMP aspects are respected during the project.
- Manage the project respecting the established timelines and coordinate all actors to align them with the project planning.
- Bachelors in Chemistry, Biochemistry or equivalent by experience
- Have already demonstrated success in C&Q coordination in projects
- Good experience in managing qualifications projects
- Planning of activities
- Good expertise in GMP/GSP Practices (V cycle, …)
- Bilingual French/English (written and spoken)
- Ability to work under pressure due to the requested flexibility and reactivity of the activities
- Ability to work in project teams in a multidisciplinary environment and a matricial organization
- Good skills and competencies level in C&Q activities organization, understanding and implementation of C&Q practices in projects, time schedule, team working,
- Good knowledge in coordination of activities
- ICT Skills (software, operating systems, hardware, etc.) SAP, MS Office
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 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.
- 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, Bio statistics, Medical Writing & Medical Information, Real World evidence services.