Senior QA Executive – Dedicated Oncology Solid Oral Block

🎯 Role Purpose

robust Quality Management System (QMS)

🔑 Key Responsibilities

• Ensure compliance with

  Schedule M and WHO-GMP

  requirements.
• Implement and maintain QMS documentation including

  SOPs, BMRs/BPRs, logbooks, deviations, CAPA, and change control

  .
• Provide QA oversight for solid oral operations:

  granulation, blending, compression, coating, encapsulation

  .
• Execute and document

  cleaning validation for cytotoxic products

  , including MACO calculations and worst-case selection.
• Ensure strict adherence to

  equipment, personnel, and area dedication

  within the oncology block.
• Support

  equipment, process, HVAC, and utility qualification

  activities from a QA perspective.
• Assist in

  manufacturing license inspections and regulatory audits

  .
• Support vendor qualification, raw material QA, and stability study initiation.
• Conduct GMP and oncology-specific training, including cytotoxic handling and spill management.

🧠 Key Skills

• Schedule M & WHO-GMP compliance
• Cleaning validation (cytotoxic products)
• Cross-contamination control
• Deviation, CAPA & data integrity (ALCOA+)
• Audit preparedness & documentation control

🎓 Qualification & Experience

• B.Pharm / M.Pharm / M.Sc. (Chemistry)

• 5–7 years of QA experience in

  solid oral dosage form manufacturing

• Hands-on exposure to

  Schedule M inspections and validation activities

• Oncology or potent compound experience preferred

📊 Reporting

QA Head / Director – Quality

(Independent of Production as per GMP)

💰 Compensation

As per industry standards, commensurate with experience.