To assist in preparation, issuance, review, and control of SOPs, BMRs, and controlled documents.
To support documentation of deviations, change controls, CAPA, and incidents in line with QMS.
To ensure compliance with cGMP, QMS, and regulatory requirements during all QA activities.
To participate in internal audits, self-inspections, and regulatory inspections.
To follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) in all documentation practices.
To maintain and update QA 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 participate in EHS (Environment, Health Safety) 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.
