QA Sterile - IPQA - Officer
QA Sterile - IPQA - Officer
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Job Description
IPQA Monitoring: Conduct inprocess checks during compounding filtration filling lyophilization and sealing to ensure sterility assurance.
Environmental Monitoring: Perform viable and nonviable particle monitoring gowning qualification and cleanroom validation as per SOPs.
Process Validation & Sampling: Support media fills sterility testing and batch release activities to ensure aseptic process validation.
Batch Record Review: Verify BMR BPR and other documentation for accuracy and compliance with GMP and data integrity standards.
Deviation & CAPA Handling: Identify investigate and report deviations outofspecifications (OOS) and nonconformities ensuring CAPA implementation.
Audit Readiness: Ensure compliance with USFDA MHRA WHO and EUGMP regulations supporting regulatory audits and inspections.
Training & Compliance: Train production personnel on aseptic techniques gowning and good documentation practices.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
