Job Description

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: ?18,000.00 - ?25,000.00 per month

Benefits:

Food provided Health insurance Life insurance Paid time off Provident Fund
Work Location: In person