Support supplier qualification activities and coordinate supplier audits to ensure compliance with regulatory and quality requirements.
Provide support during regulatory inspections and customer audits by preparing the required quality documentation and data.
Assist in drafting, reviewing, and maintaining technical Quality Control documents, SOPs, specifications, protocols, and reports.
Prepare and review stability protocols, stability reports, and ensure timely execution of stability studies.
Support the preparation and maintenance of OMS (Operational Management System) documentation.
Generate and analyze quality trends, prepare trending reports, and identify areas for improvement.
Support investigations, change controls, deviations, and CAPA activities as required.
Maintain documentation in accordance with regulatory and company requirements.