API Peptide Manufacturing ( Lyo or Rphplc)

Responsible for executing peptide manufacturing activities in compliance with GMP, SOPs, safety standards, and quality requirements while achieving production targets and ensuring operational efficiency.

Key Responsibilities

• Execute batch manufacturing activities as per approved e-BMRs, workflows, and SOPs.
• Ensure compliance with GMP, GDP, safety norms, and cleanroom practices.
• Operate critical equipment such as RP-HPLC, microwave reactors, and lyophilizers.
• Support trial, validation, and commercial batches in coordination R&D teams .
• Coordinate with IPQA, QC, Warehouse, Engineering, and other departments.
• Ensure timely equipment calibration, preventive maintenance, qualification, and process validation.
• Initiate quality and breakdown notifications and support downtime reduction.
• Maintain accurate manufacturing documentation using MES and SAP.
• Ensure manufacturing area cleanliness, regulatory compliance, and production target achievement.

Required Skills

• Knowledge of peptide API manufacturing and GMP/GDP practices.
• Hands-on experience with critical manufacturing equipment.
• Working knowledge of MES, SAP, SOPs, QMS, and e-BMR documentation.
• Understanding of equipment qualification, calibration, and process validation.
• Strong teamwork, coordination, and problem-solving skills.

MUST BE WILLING TO RELOACTE TO VIZAG