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🌟 Senior Manager – Laboratory QA (2)
📅 Date: February 13, 2025
📍 Location: Dadra – Plant
🏢 Company: Sun Pharmaceutical Industries Ltd
🔬 Ensuring Quality Compliance in the Laboratory
✔️ Supervise QC lab operations to ensure adherence to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and international regulatory standards.
✔️ Establish and maintain effective quality control systems, focusing on data integrity and precise documentation.
✔️ Evaluate and approve investigation reports, Out-of-Specification (OOS) and Out-of-Trend (OOT) findings, along with Corrective and Preventive Actions (CAPA).
🏛️ Regulatory & Audit Preparedness
🔹 Coordinate and prepare for regulatory inspections (e.g., USFDA, MHRA, WHO-GMP), customer evaluations, and internal audits.
🔹 Address audit findings promptly and ensure compliance with all regulatory commitments.
🔹 Uphold ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) to maintain data integrity.
📜 Managing Documentation & SOPs
📝 Develop, review, and approve Standard Operating Procedures (SOPs) related to laboratory quality assurance.
📑 Validate and approve analytical reports, Certificates of Analysis (CoAs), and method validation documents.
📂 Ensure organized documentation and accurate record-keeping for all laboratory processes.
🔍 Investigations & Risk Management
⚠️ Oversee investigations into laboratory deviations, equipment malfunctions, and non-conformance issues.
🔍 Identify root causes and implement effective CAPAs to address and prevent future issues.
📊 Monitor quality trends in lab operations to proactively mitigate potential risks.
🎓 Training & Process Optimization
📢 Conduct training programs for QC and QA teams on GMP, GLP, data integrity, and evolving regulatory expectations.
🚀 Promote a culture of continuous learning and process improvement for better efficiency and compliance.
📖 Stay updated with regulatory advancements and integrate necessary updates into laboratory quality practices.
🏭 Instrument Qualification & Method Validation
🔬 Supervise installation, qualification, and calibration of essential lab equipment (HPLC, GC, FTIR, UV, etc.).
📏 Ensure compliance with method validation, verification, and transfer protocols.
🤝 Work closely with QC teams to optimize analytical methods for accuracy and reliability.
🌟 Be part of a leading pharmaceutical team committed to quality and excellence at Sun Pharma!