PI
Job Description
Job description
- 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.
