Senior Executive – Production

Designation : Senior Executive

Function : Production

Functional Area : Qualifications and Validations

Job Role Summary : 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

Job Profile :

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.

Job Requirements :

• 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.
• 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.

Work / Job Experience : 6-8 Years

Type of Experience : Experience in validation of new equipment or facility expansion in regulated Pharma Industry

Academic Qualifications :

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

Job Post Link : https://tinyurl.com/4jmmy2ua