Qms Executive

Alde Medi Impex; Udham Singh Nagar District; Sur place; INR 300 000 - 550 000; Plein temps

Résumé du poste

Alde Medi Impex in India is seeking a candidate to coordinate GMP-related activities across QC, Microbiology, Production, Engineering and Validation teams. The role involves ensuring compliance, performing audits, and supporting regulatory inspections.

Key responsibilities include guidance on SOPs, deviations, CAPA, change control, risk assessment, sterile manufacturing, cleanroom practices and CCS documentation, as well as media fill, sterilization, HVAC and WFI documentation.

Qualifications

• Coordinate with QC, Microbiology, Production, Engineering, and Validation teams
• Conduct internal audits and support regulatory inspections
• Ensure GMP training, data integrity, and inspection readiness

Responsabilités

• Work with SOPs, deviations, CAPA, change control & risk assessment
• Sterile manufacture, cleanroom practices, and CCS documentation
• Coordinate with Microbiology, Production, Engineering & Validation teams
• Media fill, sterilization, HVAC, and WFI documentation
• Audit and support regulatory inspections

Description du poste

• SOPs, deviations, CAPA, change control & risk assessment
• sterile manufacture, cleanroom practices, and CCS.
• Microbiology, Production, Engineering &Validation team
• media fill,sterilization, HVAC,and WFI documentation.
• audit & support regulatory inspec

Required Candidate profile

• Coordinate with QC, Microbiology, Production, Engineering, and Validation team
• Conduct internal audits and support regulatory inspections
• Ensure GMP training, data integrity, and inspection readiness