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Document Review and Compliance Expert

2 months ago


Stirling, Stirling, United Kingdom SRG Full time

Job Summary:

SRG is seeking a highly skilled Quality Assurance Document Specialist to join our team. As a key member of our organization, you will be responsible for maintaining all activities associated with master and working documents, data and records, ensuring compliance with regulatory requirements and company policies/procedures.

Key Responsibilities:

  • Review and verify the accuracy and completeness of quality and batch documentation
  • Provide document control functions and advice to ensure compliance with regulatory requirements
  • Maintain a status tracker and provide accurate status reports on batch record review to support batch compilation activities
  • Support document archiving activities to ensure the movement of material to and from the archive is properly controlled and documented
  • Coordinate company activities to ensure that Standard Operating Procedures (SOPs) are reviewed and revised within the documented revision time span
  • Ensure that all documents are updated and mastered according to existing procedures
  • Assist in ensuring compliance with Good Manufacturing Practice (GMP) regulations

Requirements:

  • Educated to a minimum of HNC/HND level, with a degree preferred
  • Experience in document review in a regulated (GMP) environment
  • Excellent written and verbal communication skills, with the ability to communicate effectively with all levels within the organization
  • Knowledge of Quality Systems would be beneficial
  • Excellent organizational skills, with the ability to work independently and as a member of a team
  • Analytical approach to problem-solving and decision-making
  • Proficiency in Microsoft Office and data entry