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Senior Documentation Assistant
2 weeks ago
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.