QA Officer

5 days ago

Baddi, Himachal Pradesh, India Eurocrit Labs International Pvt Ltd Full time
  • QMS Element Management: Responsible for initiating, reviewing, and closing Quality Management System elements, including Deviations, Corrective and Preventive Actions (CAPA), Change Controls, Incidents, and Market Complaints.
  • Documentation & Review: Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and Quality Control (QC) data for sterile products. Prepare and update SOPs, Protocols, and Reports.
  • Audit Readiness & Compliance: Prepare for, and participate in, internal audits and regulatory inspections (FDA, EMA). Ensure the facility meets all sterile area (clean room) requirements.
  • Risk Management: Participate in Quality Risk Assessments (QRM) and investigations to identify root causes of, for example, sterile failures or OOS (Out of Specification) results.
  • Sterile Area Monitoring: Oversee environmental conditions of cleanrooms and verify compliance with aseptic manufacturing guidelines.
  • Training: Train personnel on GMP, QMS elements, and SOP adherence.
  • Validation Support: Assist in process validation, equipment qualification, and media fill activities.

Job Types: Full-time, Permanent

Pay: ₹18, ₹25,000.00 per month

Benefits:

  • Food provided
  • Health insurance
  • Life insurance
  • Paid time off
  • Provident Fund

Work Location: In person

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