Executive - Regulatory Affairs

Roles & Responsibilities

• Prepare, review, and update SOPs, specifications, methods of analysis, reports, and protocols
• Review IQ, OQ, and PQ documentation for new QC instruments
• Troubleshoot QC instruments and coordinate with authorized suppliers for technical support
• Maintain, execute, and update calibration and validation schedules for QC instruments
• Ensure adherence to GLP practices within the QC department
• Handle change control documentation related to QC activities
• Monitor laboratory management procedures in line with approved SOPs
• Participate in investigations including deviations, OOS, and OOT
• Support departmental operations and handle reporting authority responsibilities in their absence
• Perform additional duties as assigned by seniors

Qualification

• Bachelor’s or Master’s degree in Chemistry or a related field

Experience

• Experience in QC / Regulatory / Laboratory operations preferred
• Exposure to investigations (Deviation, OOS, OOT) is an advantage

Skills

• Strong attention to detail with a quality-focused mindset
• Basic understanding of peptide synthesis principles is a plus
• Good communication and interpersonal skills
• Ability to work effectively in a team-oriented environment
• Willingness to learn and adapt to new processes and technologies

About the Organisation

Piramal Group is a global business conglomerate with over three decades of experience, driven by strong ethical values and a commitment to inclusive growth. Piramal Pharma Solutions (PPS), the group’s CDMO arm, provides end-to-end drug development and manufacturing services across the pharmaceutical lifecycle through a globally integrated network in North America, Europe, and Asia. PPS supports innovators and generic companies with capabilities spanning APIs, finished dosage forms, peptides, biologics, sterile fill-finish, and advanced therapies, making it a trusted partner worldwide.