Job Summary;-

We are seeking an experienced AGM OOS/OOT to lead investigations related to Out of Specification (OOS) and Out of Trend (OOT) results within the pharmaceutical R&D; environment. The role involves overseeing laboratory investigations, identifying root causes, ensuring regulatory compliance, reviewing analytical data, and implementing CAPA to prevent recurrence. The candidate should have solid expertise in analytical method development, method validation, stability studies, laboratory investigations, and pharmaceutical quality systems.

Key Responsibilities;-

- Lead and review OOS/OOT investigations arising from analytical testing, method development, method validation, stability studies, and other R&D; activities.
- Ensure investigations are conducted in accordance with approved SOPs, cGMP, GLP, ICH guidelines, and applicable regulatory requirements.
- Perform root cause analysis using tools such as 5-Why, Fishbone Diagram, and other systematic investigation techniques.
- Review laboratory data, chromatograms, analytical worksheets, instrument logs, calculations, and raw data to identify potential laboratory errors or scientific causes.
- Ensure appropriate identification, documentation, implementation,



and effectiveness verification of Corrective and Preventive Actions (CAPA).
- Collaborate with Analytical R&D;, Formulation R&D;, Quality Control, Quality Assurance, Stability, and Regulatory Affairs teams.
- Review analytical method development, method validation, method transfer, and stability data for OOS/OOT trends.
- Monitor recurring deviations, atypical results, laboratory errors, and adverse analytical trends; recommend preventive measures.
- Ensure data integrity and compliance with ALCOA+ principles, electronic records, and audit-trail review requirements, as applicable.
- Prepare and review investigation reports, risk assessments, trend reports, and documentation for internal and external audits.
- Lead, mentor, and develop the investigation team to ensure timely closure of investigations and CAPAs.
- Support regulatory inspections, customer audits, and internal quality audits related to laboratory investigations and analytical compliance.
- Drive continuous improvement in laboratory practices, investigation quality, and right-first-time documentation.

📌 AGM - OOS/OOT (R&D Center) (Mumbai)
🏢 Navlakha Management Services
📍 Mumbai