Assistant Manager – IPQA (Sterile Manufacturing)

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FYND Talent Solutions is hiring for Shantha Biologics Private Limited, a leading biotechnology company committed to quality, innovation, and global compliance standards.

Key Responsibilities

• IPQA activities in formulation and cartridge filling operations
• GMP compliance and batch record review
• Handling deviations, CAPA, and change controls
• Ensuring adherence to sterile manufacturing and aseptic practices
• Supporting regulatory inspections and quality compliance initiatives

Required Skills

• Strong IPQA experience in sterile manufacturing
• FDA inspection experience (Mandatory)
• Knowledge of WHO, ICH, EMA, and FDA guidelines
• Expertise in quality systems, compliance, and risk management

Qualifications

• Master’s Degree in Life Sciences / M.Pharm
• 10–12 years of IPQA experience in sterile manufacturing facilities

Why Join?

• Work with one of India’s renowned biotechnology organizations
• Contribute to high-quality sterile manufacturing operations
• Opportunity to work in a highly regulated global environment
• Career growth with challenging and impactful projects

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