ProClinical is currently recruiting for a Technical Writer job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid experience to 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.
Role and Responsibilities:
- 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
- Ensure flow of communication to stakeholders
- 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
- Author, own and manage Standard Operating Procedures for Europe Supply Chain organization in the documentation system
- Manage assigned change control tasks
- Identify improvement areas and partner to develop business cases
Education and Experience:
- Bachelor degree preferably in pharmaceutical studies
- Experience in (preferably) the pharmaceutical industry
- Strong cGMP and GDP knowledge
- Strong communication and presentation skills (verbal & written)
- Proactive, assertive, well organized person with an eye for detail possessing strong analytical and social skills
- 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
- 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
- Ability to work in a fast paced environment with changing priorities
- 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
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 Lisa Edgar on +44 203 7520 313 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.