Quality Assurance

The QA Inspector is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing and packaging in compliance with established procedures

Responsibilities/ Accountabilities

• Verification of raw materials during the dispensing process
• Dispensing printed packaging materials to packaging
• Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch packaging record instructions
• Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. Specifically, to perform blend uniformity (BU) sampling
• To clean and maintain the samplings rods/dies/sample boxes used for BU sampling
• Perform IPQA testing on the manufacturing floor specifically LOD, Bulk Density, Tapped Density, Leak Test, Weight Variation test
• Ensure cleaning of manufacturing and packaging equipment, area and provide line clearance
• To perform posting of dispensed materials and samples into SAP system (ERP system) and to perform other transactions in SAP
• Involve in investigation of Deviation, OOS, OOT, or any other non-conformances
• Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP’s
• Review of online batch records, area/equipment logbooks, calibration/PMP records etc
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record
• Review of engineering records (temperature and humidity data, calibration reports and PMP records)
• To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement
• Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing
• Other duties [additional support] that management may assign from time to time

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Education Qualifications

BS in Chemistry, Analytical Chemistry, Organic Chemistry or related fields

Experience

Minimum 1-2 years’ experience in pharmaceuticals (DPI, MDI or Injectables preferred)

Skills/ Competencies

• Knowledge of Good Manufacturing Practices and 21 CFR Part820
• Ability to read, write and communicate effectively in English
• Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously
• Excellent organization skills with the ability to focus on details
• Basic computer skills (Microsoft Word, Power and Excel)