AQA Manager

Responsibilities -

• Handling of overall Analytical Quality Assurance activities.
• Handling, review, approval and closure of Quality management system Documents related to Quality control
• Deputed as Single point of contact for all the submission related activities such as Dossier submission, Regulatory submission or variation filling activities.
• Responsible as Single point of contact for customer communications.
• Review of submission or validation batch documents of manufacturing, packing and analytical reports.
• Review of Stability data & submission.
• To ensure the compliance of stability studies handled at site.
• To ensure the compliance of control samples handling at the site
• To ensure monitoring of compliance with the requirements of GDP/GLP.
• To ensure the Gowning/ De-gowning procedure to be followed during Entry/ Exit of Quality Control Lab.
• To ensure authorization of written procedures and other documents, including amendment.
• To ensure compliance of work in all sections like Raw material/Packing material, Finished goods, Inprocess, Analytical Method Validation, Process Validation, Stability Technology transfer outside testing laboratory to all section and Microbiology Section HB.
• Verification of practice versus documentation, on line entries of analytical activities in respective logs and analytical reports.
• To ensure that logbooks and all other documents related to QC are in compliance
• To ensure that the procedure followed as per SOPs and approved protocol.
• Responsible for management of quality agreement and its compliance.
• Handling, review and approve the investigation of OOS/OOT, Incident, deviation, change control at quality assurance level.
• All time readiness for QC.
• To verify schedule ,approval documents of calibration ,validation ,preventive maintenance ,qualification