This vacancy is for a Technical Writer job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. This role will be based at their offices in Breda, Netherlands and is an exciting opportunity to work for one of the world's biggest biotechnology firms that is regularly included on numerous best employers' lists worldwide.
- All activities within the company's quality system associated with the Supply Chain nonconformance investigations, CAPA records
- First point of contact for identification and alerting of potential deviations to department standard processes
- Ensure timely completion of Supply Chain non-conformances, investigations, CAPAs through the nonconformance procedures
- Support the customer service and transportation teams with a number of writing tasks including completion of Class 1 & 2 NC investigation reports
- Monitor and manage the NC-CAPA team workload for the department, including escalation when timelines for record completion are at risk
- Contribute, oversee, run and participate in root cause analysis, implementing improvements and corrective actions
- Perform trend analysis of non-conformances relating to Supply Chain
- Ensure investigations constantly reflect current requirements and expectations
- Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings
- Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals
- Ensure flow of communication to stakeholders
- Develop strong working relationships with International Quality, departmental subject matter experts and managers
- Author, own and manage Standard Operating Procedures for Europe Supply Chain organization in the documentation system
Education, Skills and Experience:
- Bachelor degree preferably in pharmaceutical studies
- Experience in (preferably) the pharmaceutical industry
- Strong cGMP and GDP knowledge
- Strong knowledge of ERP system/GMP compliance
- Experience with electronic Quality Management systems (e.g. TrackWise)
- Scientific & regulatory writing skills to produce reports in line with compliance requirements
- Exposure to root cause analysis and other investigation tools (5-whys etc.)
- Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information
- Excellent English verbal and written communication skills including technical writing, presentation and facilitation skills
- Experience with non-conformances, investigations, CAPAs
- Experience of authoring documents in a controlled document system
- Awareness of Change Control philosophy in the cGMP environment
- Understanding of the requirements of EU Good Distribution Practices
- Microsoft Office experience
- Strong data analysis skills
- Operational excellence mindset
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying, please upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.