Documentation and Systems Specialist

A large global biotechnology company working within the fields of neurodegenerative diseases, haemophilia and autoimmune disorders, is recruiting for a Documentation and Systems Specialist job. Proclinical is pleased to announce that the Documentation and Systems Specialist will join this company on a contract basis in their Switzerland-based office.

Job Responsibilities:

• Updating existing standard operating procedures, work instructions, and technical reports to align with new processes and system functionality.
• Supporting development in new procedures and work instructions.
• Creating and managing workflows, including review and approval processes, in the documented management system.
• Reviewing and approving requests for access to Oracle Agile PLM, including confirmation that appropriate training requirements have been met.
• Coordinating and/or participating in the quarterly user entitlement review for Oracle Agile PLM.
• Supporting continuous improvement projects by means of project coordination and follow-up.
• Providing support for performing analyses and solution identification.
• Ensuring compliance by monitoring timely closure of deviations, corrective/preventive actions (CAPA), and audit observations related to Oracle Agile PLM system and business processes.
• Performing investigations for deviations to determine root causes and implement CAPAs.

Skills and Requirements:

• A Bachelor's Degree or University Apprenticeship
• Experience in a regulated environment (pharmaceutical or medical technologies, space or air industries, etc) is a plus but not required.
• Excellent organisational skills with strong attention to detail.
• Strong customer focus.
• Strong communication skills.
• Strong analytical, problem solving, and data management skills.
• Flexibility, and the ability to work in teams.

To Apply:

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 Andrea Rotmistrovsky on +44 203 854 0675 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.

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