Team Member Qualifications

Educational qualification: Graduation in Pharmacy, Science, Mechanical Engineering, Chemical Engineering, Industrial Engineering, Electrical Engineering, Biotechnology or related field is mandatory.
Minimum work experience:
8 to 10 years of experience
Skills & attributes &Critical exposures
Functional Skills
• Calibration
• Change Control
• Incident Reporting
• Pharmaceutical Manufacturing
• Preventive Maintenance
• Qualification Protocols (IQ/OQ/PQ)
• Regulatory Compliance
Resident Skills
• Current Good Manufacturing Practices (cGMPS)
• Quality Management Systems
• Data Analysis
• Good Documentation Practices
• Lean Methodologies
Behavioural Skills
• Detail-oriented with strong compliance and regulatory alignment mindset
• Collaborative across vendors, engineering, QA, and cross-functional teams
• Continuous improvement orientation with problem-solving and innovation
Critical exposures
• Experience in qualification of pharmaceutical equipment, clean utilities and process equipment with basic understanding of computer system validation is desired.
• Experience in risk assessments and ensuring traceability, documentation integrity, and validation process is desired.
• Exposure to greenfield and brownfield plant setup activities is preferred.
• Exposure to audit response and compliance reporting, ensuring timely closure of gaps is preferred.