Synmedic LaboratoriesQuality Assurance
Jan. 2015 - Aug. 2018IndiaEnsured observation of cGMP guidelines, assisting in the preparation of quality documents such as SOP, Annexures, Formats, and Master documents. Maintained Document Archiving, Issuance, Distribution, Retrieval, Retention, controlled copy, display and obsolete copy files. Coordinated development and implementation of systems such as change control, deviation, Non- conformances, OOS using advanced knowledge of cGMP's, industry standards, and best practices. Documented control sample storage and destruction. Gathering, analyzed, and compiled data for audits. Handled trend analysis for purified water and APRR.
* Facilitated CAPA, tracking and monitoring status, reporting, and delivering timely implementation of CAPA, closing CAPA after Root Cause completion.
* Designed and delivering quality assurance training for staff throughout the organization, including establishing and maintaining training records.
* Supported external quality and regulatory audits, liaising with regulatory agencies and providing a wide variety of documentation.
* Prepared process validation protocol, report, and certificate of Analysis.
* Reviewed documents such as BMR & BPR, SOP's and Finish Product Specifications, ensuring adherence to GDP and GMP as well as raw material specifications.