Officer - R&D Quality

Role purpose

Location and work arrangement

• Work location is stated as fully onsite in Greater Mumbai, Maharashtra, India.
• The role reports to the Manager, R&D Q&C.

Key responsibilities

• Review change controls, method validations, test methods, technical justifications, and periodic reviews.
• Manage compliant execution, monitoring, and documentation of stability studies.
• Review OOS/OOT investigations, root-cause analyses, corrective actions, and retest evaluations.
• Conduct compliance assessments, support Gemba walks, and maintain audit and inspection readiness.
• Manage supplier qualification, audits, approved supplier lists, and supplier corrective action programs.
• Coordinate site training, monitor compliance, manage training systems, and report metrics.
• Support computerized system validation and periodic system assessments.
• Report quality metrics related to investigations, CAPAs, audits, training, and compliance.

Qualifications and experience

• Bachelor’s or master’s degree, preferably in Microbiology; other stated preferences include Biotechnology, Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.
• At least 4 years of experience in Quality Assurance, Quality Control, R&D Quality, or regulated laboratory environments.
• Working knowledge of GMP, GLP, investigations, CAPA, change control, supplier quality management, and computerized system validation.
• Experience with electronic quality management systems and document management platforms is preferred.
• Exposure to regulatory audits such as USFDA and EUGMP.