Highlights of Qualifications * Trained ISO 13485:2003 Internal auditor (TPECS) and deemed competent for RABQSA-MD- Medical device Management systems & RABQSA- AU- Management systems Auditing * Extensive Quality Assurance & Auditing experience - including but not limited to Non-Conformance, CAPA Systems, Investigations, Laboratory Controls, Production and Process controls. * In-depth knowledge and experience of implementing quality control procedures and guidelines per FDA, TNI Standards, AIHA, A2LA, CDC, and EPA. * Strong working knowledge of ISO 17025, cGMP, 21 CFR Part 11, FDA/BAM, TNI Standards, USP, AOAC & USDA Methods. * Extensive experience in writing, reviewing, updating and approving Standard Operating Procedures related to Quality assurance & test methods. * Broad experience in Aseptic Microbiology techniques. * More than 8 yrs of experience managing Quality Assurance for Environment Microbiology, cGMP microbiology, DNA /PCR Lab and Food microbiology. * Extensive experience conducting internal and external audits & working as primary contact for regulatory agency (such as NJDEP, AIHA, A2LA & EPA) & client audits. * Broad experience in conducting analysis on Food, Environment and Water samples for Microbiology parameters. Performed analysis per standard methods for drinking & waste water, USP, USDA, AOAC & FDA/BAM methods. Broad experience in documentation of research data & preparation of research projects. * Strong expertise in technical management of environmental microbiology laboratory. * Extensive experience with technical writing & documentation in a regulated compliance environment. * Extensive experience in delegating, managing, guiding & training team members. * Extensive experience in validation, verifications & calibrations of equipments used in cGMP & environmental microbiology laboratory. * Possess excellent analytical, presentation, interpersonal, communication and self-organizing skills and ability to adapt to changing work environment to implement effective solutions & strategies in an efficient manner to challenging business and technical problems. * Strong knowledge & experience of using LIMS. * Extensive work experience on taxonomy of fungi, handling various mycological and microbiological techniques in aseptic lab environment. * Review and approve cGMP & Non-GMP client contracts and quality agreements. * Published 7 full original research papers. * Technical client communication.

Highlights:

• Audit
• Good Manufacturing Practices
• Microbiology
• Performance Testing
• ISO13485
• Calibration/Validation
• Microscopy
• Mycology
• CAPA
• cGMP Compliance
• Laboratory Management
• ISO17025
• 21CRF Part11
• FDA/BAM
• USP, AOAC & USDA Methods
• Document Control