R&d Documentation Coordinator

il y a 3 semaines

Charleroi, Belgique UNIVERCELLS Temps plein

At Univercells, we are on a mission to make health equally accessible to all. Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission: biologics for all

At
**Quantoom Biosciences**, Univercells’ latest affiliate, we are on a mission to remove the barriers to making mRNA-based vaccines and therapeutics, at every stage from sequence up to mass production. We give our partners greater access to drug development and production autonomy through technical and business model innovation.

You will join an interdisciplinary team of passionate scientists, engineers, clinicians and corporate profiles committed to solving some of the biggest DNA and RNA production challenges facing vaccines and therapeutics.
**Quantoom Biosciences** has two facilities; the headquarters are based in Nívelles (Belgium), and the France Research Center focusing on offering an end-to-end DNA production platform based in Evry (France).

Due to our expansion within our
**R&D activities**, we are looking to strengthen our working force and we are looking to hire a
**_R&D Documentation Coordinator_** who will be involved in all our documentations documents within our Innovation Center located in Evry

**MISSION**:
The objectives of the
***
**_R&D Documentation Coordinator_**:

- _are to
- Centralize and uniformize documentation on site. All templates and specific project related documents must be inventoried and classified.
- Reinforce documentation rules through adequate share points and specific training (QMS and projects documentation)
- Work close to QA UNVC department to set in place the adequate QMS and following ISO 9001 regulations: be the interface for Quality Assurance on the R&D site(s).
- Be part of digitalization program for site(s) documentation

**RESPONSIBILITIES**:
1/ Documentation Coordination
- Act as support for the entire organization: general policies and instructions, Innovation Center, Analytical Development Center and project organization.
- Act as a point of contact for retrieval/setting specific documentation as required.
- Perform inventory of existing documentation
- Identify key stream for site documentation regarding site activities.
- Use and create adequate template and finalize current documentation (team support)
- Deal with long-term storage (archiving process) of information (history file) and data protection (intellectual property)
- Classify and implement rules for doc management on site (ie: versioning)
- Request UNVC QA team to help /orient general policies for documentation.
- Participate in internal gap assessment defines in UNVC QA Audit plan.
- Train and develop colleagues on the requirements and good practices around documentation.
- Train colleagues to use digital QMS tools ( SharePoint, future eQMS, digital signature.)

2/ External representation
- Provide status of on-site documentation and benchmark/sharing with equivalent R&D site

3/ Quality & Innovation
- Actively contribute to developing the Quality Management Systems within the lab and through operations on site
- Participate as doc expert for eTQ (digital QMS) implementation for the site.
- Support managers and organization by taking lead on share points management or equivalent digital tool for doc.
- continuous improvement by suggesting new processes or procedures to meet compliance objectives and improve efficiency.

4/ HSE
- Be sure rules and instructions in regards of EHS are respected

**REQUIREMENTS - QUALIFICATIONS**:

- At least 2 years of experience in a R&D &/OR GMP quality control lab environment,
- Knowledge and abilities that are typically acquired through experience in a quality environment such as biopharmaceutical or ISO environment (ie: food industry or medical devices sector),
- Strong administrative competencies,
- Good knowledge of laboratory works & constraints,
- Excellent in English & French writing,
- Experience in Quality System documentation,
- Experience in documentation writing,
- Experience in training as trainer,
- Expert in suite office use,
- Able to work in transversal mode with different stakeholder,
- Adaptable to fit with a rapidly changing environment,
- Able to create a structured work,
- Autonomous and well-organized,
- Autonomous and able to take decision,
- Sociable and empathic,
- Able to give clear instructions,
- Comfortable with computerized tools in general,
- Sense of urgency.

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