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10.06.2016

Technical Writer/Compliance Specialist Supply Chain

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.



 
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