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Technical Writer

Location: Breda, North Brabant Salary: competitive
Sector: Supply Chain and Demand Planning Type: Temporary

Technical Writer

Currently I am looking for a Technical Writer for a pharmaceutical company in Breda.

Job Scope
* All activities within the 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
* 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 & Experience
* 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 evaluate complex compliance issues
* Ability to work in a fast paced environment with changing priorities
* Work under minimal direction
* 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

Minimum requirements
* Bachelor degree preferably in pharmaceutical studies
* Experience in (preferably) the pharmaceutical industry
* Strong cGMP and GDP knowledge


Personal Skills
* 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

Are you interested in this position and do you want to apply for this opportunity? Please do not hesitate to contact the consultant about this, Niek van Alfen: at 020 522 1588 or at n.vanalfen[at]realstaffing.com.