Technical Writer/Compliance Specialist Supply Chain

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Noord-Brabant Netherlands.

The company is a well known, fast growing multinational in the pharmaceutical industry.

ROLE DESCRIPTION

As a Technical Writer you will be responsible for all activities within the companies' quality system associated with the Supply Chain nonconformance investigations, CAPA records.

RESPONSIBILITIES

• 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
• Write and route SOP revisions for reviews and approvals in the documentation system
• Manage assigned change control tasks
• Identify improvement areas and partner to develop business cases

REQUIREMENTS

• Bachelor degree preferably in pharmaceutical studies
• 5 years’ experience in (preferably) the pharmaceutical industry
• Strong cGMP and GDP knowledge
• Strong communication and presentation skills (verbal & written)
• Third level qualification in Quality or Life Sciences
• 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 (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 and audits
• 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 Good Distribution Practices
• Microsoft Office experience
• Strong data analysis skills
• Operational excellence mindset

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rosa Markus.