Job Description Summary

Preparation Review of Qualification protocols (URS, DQ, IQ, OQ, PQ etc.), media fill protocol, BMR, Risk Assessment’s, Process validation protocol, cleaning validation protocol, Impact Assessment SOP’s etc

Job Description

• Qualification and Validation of Equipment (Compounding Holding Vessel with automated skid)
• Quality Management System (Change control, Deviations, CAPA, OOS, Risk Management, Batch Failure investigation etc.)
• Dispensing of Raw material, consumable packaging materials.
• Responsible for execution of Aseptic Process Simulation (Media Fill)
• Audit and compliance (Audit response preparation, Regulatory query response preparation)
• Responsible for manufacturing of submission and commercial batches
  
  

Commitment To Diversity, Equity, And Inclusion

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.