Officer - R&D Quality

Who We Are

Location:

• Asia Pacific, India, Maharashtra, Greater Mumbai

Work Location:

• Fully Onsite

What you will do

• Officer - R&D Quality
• Responsible for ensuring Quality Management System (QMS) compliance across R&D laboratories and external service providers through management of laboratory investigations (OOS/OOT), stability programs, supplier quality activities, training compliance, documentation control, computer system validation, and quality metrics reporting. Supports regulatory compliance, inspection readiness, and continuous improvement initiatives within the R&D organization.
• Reviewing Quality documents such as change controls, method validations, test methods, technical justifications, and periodic reviews.
• Managing stability programs to ensure studies are executed, monitored, and documented in compliance with quality requirements.
• Supporting laboratory investigations, including review of OOS/OOT events, root cause analyses, corrective actions, and retest evaluations.
• Overseeing laboratory compliance activities, conducting compliance assessments, supporting Gemba walks, and maintaining audit and inspection readiness.
• Managing supplier qualification processes, supplier audits, approved supplier lists, and supplier corrective action programs.
• Serving as the site training coordinator, monitoring training compliance, managing training systems, and reporting training metrics.
• Supporting computerized system validation activities, including review of validation documentation and periodic system assessments.
• Preparing and reporting quality metrics related to investigations, CAPAs, audits, training, and compliance performance.
• Bachelor’s or master’s degree preferably in Microbiology, other preferences are Biotechnology, Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.
• 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.
• Experience with electronic quality management systems and document management platforms preferred.
• Exposure to regulatory audits like USFDA & EUGMP
• If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Key Responsibilities

• Qualifications & Experience

Preferred Qualifications

• Experience with electronic quality management systems and document management platforms preferred.