Position: Assistant Manager / Deputy Manager – Quality Assurance (Biopharmaceuticals)

Desired Profile:

• Education: Master’s/M.Tech in Biotechnology, Molecular Biology, or Biochemistry.
• Experience: 8-12 years in the Biopharmaceutical Industry with prior experience in Quality Assurance.

Key Responsibilities:

1. Quality Systems Implementation:
   • Implement quality systems for GMP manufacturing activities.
   • Prepare and implement system SOPs in the GMP facility to ensure regulatory compliance.
2. Qualification and Validation:
   • Prepare qualification protocols for clean room qualification, HVAC systems, and execute qualification activities.
   • Review technology transfer documents and initiate validation in plant scale by coordinating with cross-functional teams (CFT).
3. Documentation and Compliance:
   • Review Master Batch Manufacturing records and executed Batch manufacturing records.
   • Oversee change control, deviations, and follow-up with CFT members for effective and timely implementation of CAPA.
4. Investigations and Analysis:
   • Investigate Out of Specification (OOS) and Out of Trend (OOT) incidents to identify root causes using Quality Risk Management (QRM) tools.
5. Training and Education:
   • Conduct cGMP training sessions to educate employees on regulatory requirements.
   • Maintain and update internal departmental procedures in accordance with ICH and global regulatory guidelines.
6. Monitoring and Compliance:
   • Ensure compliance of quality systems by continuous monitoring on the shop floor.

Application Details:

• Email: Interested candidates may send their resume to ishita_m@aurigene.com
• Application Deadline: 15th August 2024

Feel free to apply if this role aligns with your qualifications and career aspirations in the biopharmaceutical industry!