Job Description
• Managing the preparation, routing, review, approval, distribution, and archival of new and revised controlled procedures and protocols.
• Monitoring, improving and maintaining to ensure compliance documents with GXP.
• Performing and assisting with qualification and validation activities.
• Handling calibration activities.
• Handling deviations, non-conformities, CAPA, change control, QRM and complaints.
• Reviewing batch records.
• Trending and reporting batch review and QMS data.
• Assisting in the execution and improvement of regulatory processes.
• Handling PQR, PSUR and PMQC.