Senior Executive – Production

Qvents.In; Dadra and Nagar Haveli; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd seeks a Senior Executive in Production (Qualification & Validation) to lead qualification of equipment and utilities, and execute process validation for OSD products in a USFDA-regulated facility.

The role involves coordinating with Production, Engineering, QA, and QC teams, supporting scale-up and tech transfer, and ensuring adherence to BMRs, SOPs, and validation protocols. A strong documentation and regulatory compliance background is essential.

Qualifications

• Six to eight years of experience in production, qualification and validation.
• USFDA-approved OSD pharmaceutical manufacturing plant experience.
• Hands-on experience with equipment qualification and process validation.
• Strong understanding of cGMP requirements, USFDA expectations, and OSD manufacturing processes.
• Knowledge of validation lifecycle concepts.
• Familiarity with production equipment such as blenders, granulators, compression and coating machines.
• Good documentation and technical writing skills.
• Working knowledge of QMS, deviation, CAPA and change control systems.

Responsibilities

• Execute and support qualification of equipment (DQ, IQ, OQ, PQ) and utilities.
• Perform process validation activities for OSD products including prospective, concurrent and re‑validation studies; prepare and review validation protocols and reports.
• Coordinate with Production, Engineering, QA and QC during qualification and validation activities; support scale-up, tech transfer and new product introduction from a validation perspective; ensure adherence to approved BMRs, SOPs and validation protocols.
• Assist in troubleshooting process or equipment-related issues during validation batches.
• Prepare and maintain validation documentation in compliance with USFDA, cGMP and ICH guidelines (Q8, Q9, Q10); ensure data integrity and ALCOA+; maintain logs for audits and inspections; support regulatory inspections and internal/customer audits related to validation.
• Participate in risk assessments (FMEA, risk analysis); support change control evaluations and impact assessments; contribute to continuous improvement in production and validation processes.

Education

Bachelor’s degree in Pharmacy

M.Pharm

Job description

Job Information

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

Location and Employment Type

• Full Time
• India | Dadra and Nagar Haveli | Dadra
• Posted 3 days ago

Company

Sun Pharmaceutical Industries Ltd