Senior Officer

1 week ago


Mumbai, Maharashtra, India SUN PHARMA Full time
Job Summary

We are seeking an experienced Senior Officer to join our team at SUN PHARMA in a key role involving scale-up and process validation. The successful candidate will be responsible for ensuring the smooth execution of technology transfer, scale-up, exhibit, and process validation batches.

Key Responsibilities
  • Scale-up and Process Validation: Responsible for planning and executing scale-up and process validation batches, ensuring timely completion and compliance with quality standards.
  • Documentation and Review: Documents all scale-up and process validation activities, including new production introduction forms, scale-up reports, and review of CMO business management reviews.
  • Quality Assurance: Ensures that products are produced and stored according to relevant documentation, maintaining desired quality standards.
  • Troubleshooting and Investigation: Handles troubleshooting batches for data comparison and root cause investigation at contract manufacturing organizations (CMOs).
  • Packing and Stability Operations: Coordinates packing operations and stability charging on time.
  • Equipment Preparation and Maintenance: Monitors and prepares equipment for scale-up, exhibit, and process validation batches.
  • Reporting and Compliance: Accurately reports production activities and ensures compliance with various instructions provided in master files, failure mode and effects analysis, risk assessment, business management reviews, and maintenance burden reviews.
Requirements and Qualifications

To succeed in this role, you should have:

  • A bachelor's degree in a relevant field.
  • At least 5 years of experience in pharmaceutical manufacturing, preferably in a similar role.
  • Excellent communication and problem-solving skills.
  • A strong understanding of GMP regulations and industry standards.
Salary and Benefits

The estimated salary range for this position is ₹600,000 - ₹900,000 per annum, depending on qualifications and experience. Additional benefits include health insurance, retirement plans, and opportunities for professional growth.


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