Assistant Manager

Sapigen Biologix Private Limited; Khordha; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Sapigen Biologix Private Limited in India is seeking a skilled microbiology/QA professional to oversee cGMP, GLP, GDP compliance across manufacturing and QA. You will prepare and review validation protocols, SOPs, STPs, specifications and reports, and supervise sterility testing of RM, PM, bulk and finished products.

The role involves leading OOS/OOT/deviation investigations, maintaining QMS for change control and CAPA, reviewing qualifications of autoclaves and isolators, assisting audits, and

Responsibilities

• Ensuring cGMP, GLP, GDP and safety compliance in all working areas
• Preparing and reviewing validation protocols, SOPs, STPs, specifications and reports
• Sterility and BET testing of RM, PM, bulk and finished products
• Leading OOS/OOT/deviation investigations; following QMS for change control and CAPA
• Reviewing facility qualification, media-fill protocols, and qualification of autoclaves, isolators and tunnels
• Reviewing EMP and water trends, analytical data, CoAs and batch release
• Training and qualifying microbiologists; preparing JDs and training schedules
• Risk assessment and contamination control strategy
• Supporting internal/external audits and coordinating with vendors and cross-functional teams

Job description

Role & responsibilities

• Ensuring cGMP, GLP, GDP and safety compliance in all working areas
• Preparing and reviewing validation protocols, SOPs, STPs, specifications and reports
  Sterility and BET testing of RM, PM, bulk and finished products
• Leading OOS/OOT/deviation investigations; following QMS for change control and CAPA
• Reviewing facility qualification, media-fill protocols, and qualification of autoclaves, isolators and tunnels
• Reviewing EMP and water trends, analytical data, CoAs and batch release
• Training and qualifying microbiologists; preparing JDs and training schedules
  Risk assessment and contamination control strategy
• Supporting internal/external audits and coordinating with vendors and cross-functional teams