Conduct comprehensive technical reviews of analytical and microbiological testing data, including finished products, in-process samples, stability samples, raw materials, and environmental samples, ensuring compliance with GMP standards. This includes evaluating method performance and verifying data integrity elements such as good documentation practices and audit trails.
Lead and drive laboratory investigations, deviations, and change controls to resolution, identifying root causes and implementing appropriate CAPAs.
Act as a Subject Matter Expert (SME) for electronic QC database systems and laboratory data integrity compliance tools (e.g., OpenLab) to support QC laboratory operations.
Develop and refine technical documents such as specifications, protocols, SOPs, and templates. Update and enhance analytical methods, protocols, and associated SOPs.
Mentor laboratory analysts at all levels by providing guidance on GMP fundamentals, chromatographic/spectrographic systems, and general analytical testing practices.
Support regulatory filings and product import/export needs by providing laboratory information and documentation as requested by site management and customers.
Monitor product trends, identify out-of-trend results, and manage the Site Stability Program.
Assess method reliability and review data trends for inclusion in PQR/APR.
Represent QC laboratories effectively during customer and regulatory audits.
Oversee the transfer of analytical methods into the QC laboratory, collaborating with QC and QA to ensure successful implementation.
Lead or participate in continuous improvement projects focused on methods or method execution.
Provide support for instrument troubleshooting, repair, and calibration in the QC laboratories.
Handle hazardous waste as part of job responsibilities, including attending mandatory annual hazardous waste training and demonstrating competency through testing.
Qualifications:
Bachelor’s degree in Chemistry, Biology, or Life Sciences.
5–7 years of experience in a GMP-regulated environment.
