QA/Investigation Specialist/Experience in Pharma & Lab Compliance

Role & responsibilities

Quality Assurance / Investigation Specialist | 10+ Years Experience in Pharma & Lab Compliance

Experienced Quality & Investigation Specialist with 10-12 years of expertise in OOS, OOT, OOE, and laboratory error investigations in the pharmaceutical industry. Proven ability to analyze trends, evaluate CAPA effectiveness, and ensure regulatory compliance for lab instruments and processes.

Key Skills & Expertise:

✅ OOS/OOT/OOE/INV Investigations In-depth evaluation and resolution of lab deviations
Instrument Audit Trail Review Ensuring compliance with periodic audits

✅ CAPA Effectiveness Evaluation Assessing the impact and efficiency of corrective actions

✅ Calibration & Breakdown Analysis Risk assessment and impact evaluation of equipment failures

✅ Extended Investigations Experience in process evaluations and complex investigations

✅ Experimental Analysis & Protocol Preparation Designing protocols with scientific rationale

✅ Data Trending & Interpretation – Monitoring trends and driving proactive improvements

✅ MS Office Proficiency – Expert in Excel, PowerPoint, and data visualization

💡 Passionate about quality control, regulatory compliance, and continuous improvement to drive excellence in pharmaceutical manufacturing.

Kindly email your resume on anuja.nirgun@inventia.com