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Regulatory Document Control Professional

2 months ago

Stirling council area Scotland, United Kingdom SRG Full time

Job Summary

SRG is seeking a highly skilled Quality Assurance Document Specialist to join their team. As a key member of the Quality Assurance department, the successful candidate 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 quality and batch documentation to ensure accuracy and compliance with regulatory requirements.
  • Provide document control functions and advice to ensure seamless document management.
  • 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/revised within the documented revision time span.
  • Ensure that all documents are updated and mastered according to existing procedures.
  • Assist in compliance with Good Manufacturing Practice (GMP) regulations.

Requirements

  • Education: HNC/HND as minimum, degree preferred.
  • Experience: Document review in a regulated (GMP) environment.
  • Excellent written and verbal communication skills; able to communicate effectively with all levels within the organisation.
  • Knowledge of Quality Systems would be beneficial.
  • Excellent organisational skills.
  • Ability to work independently and as a member of a team.
  • Analytical approach to problem solving and decision making.
  • IT literate with proficiency in Microsoft Office and data entry.