Pharma Technical Writer
Pharma Technical Writer
rue de Namur 73D Bruxelles Belgium
Consultant employee or freelancer
For nearly 15 years, the largest laboratories in the world have been showing their confidence in our company. Specialized in pharma, biotech and medical devices, we support our customers from research to product launch.
We cultivate a human-scale company spirit that allows us to personally follow our 450 employees – each of them known for their technical and scientific expertise. Through our regional subsidiaries in France, Belgium and Switzerland, we offer everyone geographical stability, without a mobility clause in the contracts.
CONSULTYS BENELUX is looking for Pharma/medical Devices Technical writer with at least 3 years of similar experience in the Pharma/Biotech or medical Devices sector.
As a consultant (employee or freelancer) you will bring your expertise to the client team.
The main duties of the role is to author reports and templates and manage documentation for the client device development team, supporting activities relating to the device development, transfer , assembly process qualification and clinical/commercial manufacturing support.
The main activities of this role will be:
- Source data from batch records, lab books, data management systems and existing reports, evaluating the information, and generate summary reports
- Author device development protocols, reports, risk assessment and templates in English,
- Verify data
- Data mine from physical and electronic repositories
- Manage, analyze and visualize data,
- Generate training materials based on lessons learned exercises
- Present/discuss documentation in project team meetings,
- Liaise with client departments or external partners to ensure documentation meets stakeholder’s needs (quality, regulatory, commercial manufacturing, etc…).
All these activities will be performed in compliance with the client Health, Safety & Environment (HSE) as well as Quality policies and standards and with the regulatory requirements for each development phase of the products.
START DATE: asap
WORK LOCATION: Walloon Brabant, Belgium
Minimum of 3 years working in the pharmaceutical/biologics/medical device industry. Operational GMP or quality experience would be a distinct advantage
Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements
Demonstrate ability to independently analyse data and information to draw conclusions and make effective decisions
Must be able to identify and assess risks together with proposing corrective actions within area of expertise
Help others solve problems in a creative and practical way through development of solutions from innovative problem solving activities
US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques.
Experienced in CAPA management.
Must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental
Root cause analysis and risk management/assessment skills will be a distinct advantage.
Do you want to integrate the consulting world into a human-sized company that values the individual and the performance? Do you want to invest in long-term innovative projects? To share your skills in a close-knit team where experiences are shared freely? So, join us! We offer you an attractive salary and fringe benefits. You will work in a stimulating international environment, with numerous opportunities for personal development.