About this role
- Review raw material analytical reports, test results, and laboratory documentation.
- Verify compliance with approved specifications, STPs, SOPs, and pharmacopoeial requirements.
- Review chromatograms, spectra, calculations, and analytical worksheets for accuracy.
- Ensure compliance with ALCOA+ principles and data integrity requirements.
- Review and approve raw material Certificates of Analysis (CoA).
- Coordinate with QC analysts and warehouse for timely material disposition.
- Review deviations, OOS/OOT results, and support investigations as required.
- Ensure GMP and regulatory compliance during documentation review.
- Maintain accurate records in LIMS/ERP or other laboratory systems.
- Participate in internal audits, regulatory inspections, and customer audits.
- Support method verification, laboratory investigations, and continuous improvement initiatives.
- Ensure timely review and release of raw material testing documents to avoid production delays.