Description
Experienced with Master Batch Records, SAP, MES, and Trackwise. * Domestically participated with compliance and supplier audit group and leading Pharma site internal and self-inspections to meet the FDA six Quality Systems. * Managed GMP documentation (policies, guidelines and plans) for audit team activities. * Coached associates for internal and external auditing. * Supported equipment validation by managing equipment validation and systems assessment of analytical equipment associated with various laboratory groups. Senior Scientist: Stability & QC Laboratory: 1995 - 2008 * Managed laboratory investigations and ensured compliance with the appropriate regulations and guidelines. * Reviewed and verified laboratory data to ensure analytical integrity of data acquisition by LIMS within GMP, SOP requirements for analytical method validation, stability, quality control, calibration studies, checking cross-references, specification limits. * Performed periodic self-inspections for inspection readiness to assure GMP compliance. * Actively participated in investigative issues related to compliance, market recall, consumers (i.e. Pharmacy, patient) complaints and internal investigations. * Performed analysis of Solid Dosage Form, actives, and complaint samples. * Proficient in usage of HPLC Systems, data acquisition systems and dissolution systems. Managed instrumentation IQ/OQ/PQ in the laboratory. * Trained, assisted and guided employees for cGMP, GLP and laboratory instrumentation, analytical techniques, methods and LIR/OOS.
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