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Sterile Injectables Manufacturing Expert

7 days ago


Delhi, Delhi, India Medivant Healthcare Full time

About Company:
Medivant Healthcare is a pioneer in the pharmaceutical industry, providing high-quality products reliably, efficiently, and affordably for hospitals, healthcare providers, and their patients. We operate two fully automated CGMP FDA registered facilities in Arizona, producing Single Dose liquid injectable vials and pre-filled syringes.

Job Description:

Key Responsibilities:
  • Manufacturing Oversight: Monitor sterile injectable manufacturing activities on the shop floor to ensure adherence to cGMP, SOPs, and regulatory requirements.
  • Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR): Prepare, review, and approve BMRs and BPRs to ensure accurate documentation and compliance with manufacturing procedures.
  • In-Process Quality Checks: Perform quality checks during manufacturing stages to ensure critical process parameters and product specifications are met.
Quality Management System (QMS):
  • Change Control: Review and approve change control proposals, assessing the impact of changes on validation and regulatory compliance.
  • Deviation Management: Investigate deviations, identify root causes, and implement corrective actions.

Required Skills and Qualifications:

  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines.
  • Strong analytical and problem-solving skills.