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Senior Documentation Assistant

2 weeks ago


Delhi NCR Mumbai Kolkata, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000
Job Opportunity

We are seeking a diligent and meticulous individual to join our team as an Apprentice. The successful candidate will play a pivotal role in supporting the preparation, issuance, review, and control of SOPs, BMRs, and controlled documents.

  • To assist in the creation, revision, and approval of standard operating procedures, best manufacturing practices, and other controlled documents.
  • To support the documentation of deviations, change controls, CAPA, and incidents in accordance with quality management systems.
  • To ensure adherence to current Good Manufacturing Practices (cGMP), quality management systems (QMS), and regulatory requirements during all quality assurance activities.
  • To participate in internal audits, self-inspections, and regulatory inspections to maintain compliance.
  • To follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) in all documentation practices.
  • To maintain and update quality assurance logbooks, training records, calibration records, and archives.
  • To support qualification, validation, and calibration documentation as per GMP guidelines.
  • To assist in vendor qualification processes and related documentation.
  • To contribute to environmental, health, and safety (EHS) initiatives and ensure workplace safety compliance.
  • To report any deviations, incidents, and unsafe practices immediately to supervisors.
  • To contribute to continuous improvement initiatives related to QMS, GMP, and safety standards.
  • To support stability study documentation and ensure adherence to data integrity requirements.

This is an excellent opportunity for individuals who are enthusiastic about working in a dynamic environment and contributing to the growth and success of our organization. If you are motivated, organized, and possess excellent communication skills, we encourage you to apply for this position.