Assistant manager

Job Description Summary

We are seeking a detail-oriented and innovative Automation Engineer to join our Quality Department. The ideal candidate will be responsible for reviewing, implementing, and maintaining automated systems and tools that enhance quality assurance processes, improve product reliability, and ensure compliance with industry standards.

Job Description

• Review and support the validation of computer systems for GxP systems at Endo India (Par Formulations), Indore SEZ plant.
• To review system capability to meet GAMP 5 requirement & 21 CFR requirement for electronic data management.
• To review the vendor investigation/assessment and corrective action incase of software failure.
• To involve in to the investigation/risk assessment in site automation systems.
• Ensure data storage, archival, and retrieval capabilities meet requirements in all GxP systems.
• Prepare, review and approval of documentation for automated systems, including SOPs, validation protocols as per GAMP 5 & 21CFR requirement.
• Collaborate with cross-functional teams (Engineering, Production, IT) to integrate automation into existing workflows.
• Ensure compliance with relevant regulatory standards (e.g., EU, FDA, GMP etc.).
• Conduct training sessions for quality and production staff on automation tools and best practices.
• Implement automated testing frameworks and tools for product validation and verification.
• Develop and review User Requirement Specifications (URS) for GxP systems concerning control and automation needs.
  
  

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