Title:  Senior Executive - Production (Qualification & Validation)

Job Purpose

Key Responsibilities

Qualification & Validation Activities

• Execute and support qualification of:
  • Equipment (DQ, IQ, OQ, PQ)
  • Utilities (HVAC, purified water, compressed air, etc.)
  • Production areas and systems
• Perform process validation activities for OSD products including:
  • Prospective, concurrent, and re‑validation studies
• Prepare, review, and execute validation protocols and reports as per approved SOPs.
• Ensure validation activities are completed within defined timelines.

Production Support

• Coordinate with Production, Engineering, QA, and QC teams during qualification and validation activities.
• Support scale‑up, technology transfer, and new product introduction from a validation perspective.
• Ensure adherence to approved BMRs, SOPs, and validation protocols during execution.
• Assist in troubleshooting process or equipment‑related issues during validation batches.

Documentation & Compliance

• Prepare and maintain validation documentation in compliance with:
  • USFDA
  • cGMP
  • ICH guidelines (Q8, Q9, Q10)
• Ensure data integrity and compliance with ALCOA+ principles.
• Maintain proper documentation, logs, and records for audits and inspections.
• Support regulatory inspections, internal audits, and customer audits related to validation.

Continuous Improvement

• Participate in risk assessments (FMEA, risk analysis) related to validation activities.
• Support change control evaluations and impact assessments.
• Contribute to continuous improvement initiatives in production and validation processes.

Educational Qualification

• Bachelor’s degree in:
  • Pharmacy (B.Pharm / M.Pharm)

Experience

• 6–8 years of experience in:
  • Production / Qualification / Validation
  • USFDA‑approved OSD pharmaceutical manufacturing plant
• Hands‑on experience with equipment qualification and process validation is essential.

Technical Skills & Knowledge

• Strong understanding of:
  • cGMP requirements
  • USFDA regulatory expectations
  • OSD manufacturing processes
• Knowledge of validation lifecycle concepts.
• Familiarity with production equipment such as:
  • Blenders, granulators, compression machines, coating machines
• Good documentation and technical writing skills.
• Working knowledge of QMS, deviation, CAPA, and change control systems.

Behavioral & Soft Skills

• Strong attention to detail
• Good analytical and problem‑solving skills
• Effective communication and coordination abilities
• Ability to work in cross‑functional teams
• Compliance‑oriented and quality‑focused mindset

Preferred / Added Advantage

• Exposure to regulatory audits (USFDA, MHRA, WHO, etc.)
• Experience in validation of new equipment or facility expansion
• Knowledge of cleaning validation (basic level)