Technical Expert

5 days ago

Pune, Maharashtra, India Fresenius Kabi Full time ₹ 20,00,000 - ₹ 25,00,000 per year
  1. Hi,

Pl send Updated CV on Rashmi.-

Details as below :

1. Position : Senior Technical Expert- Quality Assurance

Key Responsibilities: - Validation Profile

  • Validation Planning & Execution:

  • Develop, review, and approve Validation Master Plans, Validation Protocols (IQ/OQ/PQ), and Reports for equipment, utilities, and manufacturing processes.

  • Lead validation activities for injectable dosage forms, including aseptic processing, lyophilization, and sterile filtration.

  • Ensure validation activities comply with cGMP, FDA, EU, and other applicable regulatory standards1.

  • Documentation & Compliance:

  • Maintain and update Site Master File, Annual Product Reviews, and Validation Summary Reports 2.

  • Review and approve SOPs, Work Instructions, and Change Control documentation.

  • Ensure traceability and archival of all validation documents.

  • Cross-functional Collaboration:

  • Coordinate with Production, Engineering, QC, and Regulatory Affairs to align validation efforts with project timelines.

  • Support audits and inspections by providing validation documentation and responding to observations.

  • Deviation & CAPA Management:

  • Investigate validation-related deviations and implement Corrective and Preventive Actions (CAPA).

  • Conduct risk assessments and impact analyses for changes to validated systems 3.

  • Training & Support:

  • Train operators and analysts on validation protocols and regulatory expectations.

  • Provide technical support during equipment qualification and process validation.

2. Position : Technical Lead- Quality Assurance

Key Responsibilities: Batch Release

  • Batch Documentation Review:

  • Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for completeness, accuracy, and compliance with cGMP.

  • Ensure all documentation supports batch release and adheres to data integrity standards.

  • Product Release Authorization:

  • Authorize release of raw materials, intermediates, and finished injectable products.

  • Ensure specifications are met and documented evidence supports product quality.

  • Deviation & CAPA Management:

  • Escalate discrepancies and deviations promptly.

  • Participate in investigations and ensure Corrective and Preventive Actions (CAPA) are implemented and closed.

  • Compliance & Regulatory Support:

  • Ensure batch release activities comply with FDA, EU, and WHO GMP guidelines.

  • Support internal and external audits by providing batch documentation and responding to queries.

  • Cross-functional Collaboration:

  • Coordinate with Production, QC, Regulatory Affairs, and Warehouse teams to ensure timely and compliant product disposition.

  • Support continuous improvement initiatives in batch release processes.

  • Documentation Control:

  • Manage issuance, filing, and archival of executed batch records.

  • Maintain batch documentation library and ensure traceability.

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