Join Our Team as a Process Specialist

2 weeks ago

Cuddapah, Andhra Pradesh, India beBeeProcess Full time ₹ 12,00,000 - ₹ 15,00,000
Process Specialist Role

We are seeking a skilled Process Specialist to join our team. As a Process Specialist, you will be responsible for product transfer and technology absorption in the FTO-SEZ process unit.

Key Responsibilities:
  • Execution and monitoring of confirmatory submission pre-validation processes qualification batches
  • Process simplification, machine change, batch size change, and other routine validation activities
  • Review of investigations arising from incidents, out-of-specifications, out-of-trends, product failures, and market complaints to identify root causes and implement corrective and preventive actions
  • Process and product risk evaluation and recommendation on proposed changes
Collaboration:
  • Coordination with Production, Quality Assurance, Regulatory Affairs, Quality Control, and Supply Chain Management teams
  • Participation in Process Safety Management activities and ensuring safety measures during execution of confirmatory submission process qualification batches
Documentation:
  • Preparation and review of various documents including confirmatory submission, pre-validation, process qualification batches protocol, report, master formula record, manufacturing instruction, packing instruction, process order raw material, and process order packing material
  • Equivalency report, justification report, hold time study protocol and report, stability protocol, and SHE report preparation for site transfer products

The ideal candidate will have excellent communication skills, strong analytical abilities, and experience working in a fast-paced environment.

This is an exciting opportunity to work with a talented team and contribute to the success of our organization.

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