Senior Executive - Production (Qualification & Validation)
SUN PHARMA · Dadra & Nagar Haveli
- Experience6–8 yrs
- SalaryNot disclosed
- Work modeonsite
- Levelsenior
- Posted13 Sept 2026
About SUN PHARMA
SUN PHARMA is hiring in Dadra & Nagar Haveli in pharma biotech. This role looks for around 6+ years of experience.
Skills
- Equipment Qualification
- Process Validation
- cGMP
- USFDA
- OSD Manufacturing
- Validation Protocols
- ICH Q8
- ICH Q9
- ICH Q10
- ALCOA+
- Pharmaceutical Manufacturing
- Risk Assessment
- FMEA
- Change Control
- Deviation Management
- CAPA
- Quality Management Systems
- Technical Writing
The role
A process engineer at a pharmaceutical manufacturing company executes equipment qualification, process validation, and cGMP compliance for oral solid dosage production, using USFDA requirements and ALCOA+ principles. The role manages validation protocols, regulatory documentation, and production support across equipment, utilities, and manufacturing processes.
Full 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 systemsPerform process validation activities for OSD products including:Prospective, concurrent, and re‑validation studiesPrepare, 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:USFDAcGMPICH 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 / ValidationUSFDA‑approved OSD pharmaceutical manufacturing plantHands‑on experience with equipment qualification and process validation is essential. Technical Skills & Knowledge
Strong understanding of:cGMP requirementsUSFDA regulatory expectationsOSD manufacturing processesKnowledge of validation lifecycle concepts.Familiarity with production equipment such as:Blenders, granulators, compression machines, coating machinesGood documentation and technical writing skills.Working knowledge of QMS, deviation, CAPA, and change control systems. Behavioral & Soft Skills
Strong attention to detailGood analytical and problem‑solving skillsEffective communication and coordination abilitiesAbility to work in cross‑functional teamsCompliance‑oriented and quality‑focused mindset
Preferred / Added Advantage
Exposure to regulatory audits (USFDA, MHRA, WHO, etc.)Experience in validation of new equipment or facility expansionKnowledge of cleaning validation (basic level)