Document Control Specialist (QA)

Syqe is a med-tech company developing technologies that enable the precise delivery of a wide range of therapeutic molecules by inhalation. Utilizing its breakthrough technology, Syqe aims to relieve the suffering of as many patients as possible in the fastest possible way.

The Quality Assurance – Document Control Specialist is responsible and accountable for all aspects of document control, according to established procedures. Communicates and tracks training activities associated with new or changed documents. Maintain a Quality Management System (QMS) in accordance with GMP guidelines.

Responsibilities:

• Maintain the documentation control system to ensure all records are accurate, up-to-date, and compliant with regulatory standards.
• Maintaining electronic and hard copy document files and keeping records for off-site storage.
• Maintaining different QA logs (Deviations, Change Control records, NCR’s, CAPA’s, internal audits, etc.)
• Support and assist all functional departments with documentation control functions.
• Distribution of Master batch records and QC forms that are product-related.
• Perform daily QA tours on the production floor to ensure compliance and proper documentation within the batch records.
• Provide guidance and training to staff on quality procedures, protocols, and GMP requirements.
  
  

• Bachelor’s degree - an advantage
• 1-3 years' experience in document control, including experience with quality management systems.
• Experience with electronic documentation management systems - an advantage
• Well-organized and detail-oriented (spot errors), solid written and verbal communication skills, and a proven ability to multitask.
• Ability to read and understand written directions, including SOPs, GXP standards, etc.
• Language skills: Excellent English and Hebrew writing skills – required.
• Computer Skills: High level of proficiency in Microsoft products such as Word and Excel, as well as the ability to learn other applications.
• Develop and deliver on assigned objectives within the requested timeframes.
• Strong interpersonal skills and ability to effectively collaborate with others in a dynamic team environment.