Job Description

Job Purpose

To support and execute qualification and validation activities related to production equipment, utilities, and processes in an Oral Solid Dosage (OSD) manufacturing facility, ensuring compliance with USFDA, cGMP, and regulatory requirements.

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)