Mfg. QA Specialist Job

Mfg. QA Specialist is needed to perform the following duties:

• Review the master batch records for manufacturing, inspection/packaging, and aseptic process simulations (Media fills).
• Perform line clearances and review documentation (circular charts, autoclave tapes, etc.) to allow operations to initiate production (release to fill).
• Perform a visual inspection of the finished product and AQL sampling/inspection.
• Review of in-process documentation. Audit manufacturing rooms for adherence to cGMP and SOPs.
• Audit the maintenance of a cleaning and sanitary environment.
• Review daily/weekly/monthly and bi-monthly logbook entries for completeness.
• Review, approve, and issue verified -clean green release stickers to operations.
• Monitor the aseptic behaviors in clean rooms and train/coach the operators.
• Impart the training about clean room behaviors and cGMP practices for sterile drug product manufacturing.
• Observe/mentor personnel on aseptic performance. Obtain and maintain gown certification for clean room entry.
• Batch records review and protocols review and monitoring of the execution activities.
• Conducting self-inspections and internal audits to ensure adherence to the laid-down procedures.
• Author/review the Quality Risk assessments. Participate in Regulatory Audits and External Audits.
• Prepare and reviews the commissioning qualification validation documents.
• Review of the process equipment data generated during the batch manufacturing
• Develops procedures as an Expert per the regulatory requirements for implementation of software applications for pharmaceutical processing.

Bachelor’s degree is required in pharmacy or pharmaceutical science or pharmaceutics