Job
Description
1. Laboratory Quality Compliance: Ensure QC laboratory operations comply with GLP, GMP, and global regulatory standards. Implement and maintain laboratory quality systems, including data integrity controls and documentation practices. Review and approve laboratory investigations, Out-of-Specification (OOS) and Out-of-Trend (OOT) reports, and Corrective and Preventive Actions (CAPA). 2. Regulatory & Audit Compliance: Prepare and participate in regulatory inspections (USFDA, MHRA, WHO-GMP, etc.), customer audits, and internal audits. Ensure timely implementation of audit observations and compliance commitments. Maintain compliance with ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) principles for data integrity. 3. Documentation & SOP Management: Develop, review, and approve Standard Operating Procedures (SOPs) related to laboratory quality assurance. Oversee the review and approval of analytical reports, Certificates of Analysis (CoAs), and method validation protocols. Ensure proper documentation control and record-keeping for all QC lab activities. 4. Laboratory Investigations & Risk Management: Lead investigations related to laboratory deviations, instrument failures, and non-conformities. Identify root causes and implement corrective and preventive actions (CAPA). Monitor laboratory trends to proactively mitigate risks affecting product quality. 5. Training & Continuous Improvement: Conduct training sessions on GMP, GLP, data integrity, and regulatory updates for QC and QA personnel. Promote continuous improvement initiatives to enhance lab efficiency and compliance. Stay updated on changes in pharmaceutical regulations and implement necessary changes in lab QA practices. 6. Instrument Qualification & Method Validation: Oversee qualification and calibration of analytical instruments (HPLC, GC, FTIR, UV, etc.). Ensure compliance with method validation, verification, and transfer protocols. Collaborate with QC teams to ensure analytical methods are robust and compliant.
