Officer - R&D Quality

Overview

Ensure Quality Management System compliance across R&D laboratories and external service providers, covering laboratory investigations, stability programs, supplier quality, training compliance, documentation control, computer system validation and quality metrics reporting.

What you'll do

• Review quality documents such as change controls, method validations, test methods, technical justifications and periodic reviews.
• Manage stability programs to ensure studies are executed, monitored and documented in compliance with quality requirements.
• Support laboratory investigations, including review of OOS/OOT events, root cause analyses, corrective actions and retest evaluations.
• Oversee laboratory compliance activities, conduct compliance assessments, support Gemba walks and maintain audit and inspection readiness.
• Manage supplier qualification processes, supplier audits, approved supplier lists and supplier corrective action programs.
• Serve as site training coordinator, monitor training compliance, manage training systems and report training metrics.
• Support computerized system validation activities, including review of validation documentation and periodic system assessments.
• Prepare and report quality metrics related to investigations, CAPAs, audits, training and compliance performance.

What you'll need

• Bachelor's or master's degree, preferably in Microbiology; Biotechnology, Pharmacy, Chemistry, Life Sciences or a related scientific discipline are also accepted.
• Minimum 4 years of experience in Quality Assurance, Quality Control, R&D Quality or regulated laboratory environments.
• Working knowledge of GMP, GLP, laboratory investigations, CAPA, change control, supplier quality management and computerized system validation.

Nice to have

• Experience with electronic quality management systems and document management platforms.
• Exposure to regulatory audits such as USFDA and EUGMP.

Details

• Location: Greater Mumbai, Maharashtra, India.
• Work mode: Fully onsite.
• Reports to: Manager, R&D Q&C.