Dy.Manager- API QA

Role & responsibilities

• Responsible for qualification raw material, packing material vendors and Periodical assessment of vendor performance.
• Responsible for site audit management, compliance, and implementation of CAPA.
• Responsible for Nitrosamine & NDSRI impurity assessment and ensure compliance with SOP and regulatory guidelines.
• Responsible for quality risk management and implementation of mitigation plans.
• Responsible for elemental impurities assessment and ensure compliance with SOP and regulatory guidelines.
• Responsible for Cleaning validations.
• Responsible for Process validations.
• Responsible for annual product quality review (APQR) and Continued process verification (CPV).
• Responsible for batch release activities.
• Responsible for qualification of transporters and transport validation program.
• Responsible for qualification of contract testing laboratories.
• Should have awareness about quality management systems like change control, deviations, complaints, investigation & root cause analysis

Preferred candidate profile

API experience is mandatory

Perks and benefits

As per company norms