Qa Executive

Job Description

Handling, storage and retrieval of all the documents pertaining to facility on operation of the functional departments. Deploying Good Documentation Practices throughout all the functions. Allotment of reference numbers, Formatting, distribution, control, revision, retrieval and storage of all master documents. Maintaining of master list of documents. Maintaining online documentation. Issuance of Formats, LNBs & Log books to all departments. Preparation of QA&RA SOPs. Monitoring of Instruments and Equipment calibrations. To involve internal quality and regulatory compliance audits across all the functions. Handling of Training Records across all the functional departments. Monitoring for compliance across all functional departments. Providing adequate support to R&D teams to execute the required documents for regulatory submissions. Review of all quality documents which includes SOPs, Formats, Equipment/Instrument qualifications/ calibrations , drug excipient compatibility studies, API characterization, API solubility studies, Stability studies, Stress studies, Other studies, Method development reports, Specifications, STPs, MFR, method validations, Method transfers, PDR etc. Reviewing of LNBs, Raw data & Log books for data integrity issues.