ProClinical is currently recruiting for a Techinical Writer job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid Supply Chain experience their team at their offices in the Netherlands. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally.
- All activities within quality system associated with the Supply Chain nonconformance investigations, CAPA records
- 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
- 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
- Develop strong working relationships with International Quality, departmental subject matter experts and managers
- Facilitate (chair) periodic quality management review meetings as well as cross-departmental (Regional Supply Chain/Security/International Quality) meetings addressing compliance/quality topics
Skills and Requirements:
- Bachelor degree preferably in pharmaceutical studies
- Experience in (preferably) the pharmaceutical industry
- Strong communication and presentation skills (verbal & written)
- Enthusiastic person willing to learn and grow position-specific skillset
- 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
- 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 or if you have any questions, please call Sayf Jabbar on +44 203 8281 920 or 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.