FDA Job Vacancies in Maharashtra

URGENT REQUIREMENT WORKING HOURS - 9:30 - 6- basic accounts working experince - transfering the data ( fda ) - working experince in excel - basic knowledge of accounts / tally / ERP systems( FEMALE CANDAIDATES )JOB LOCATION - VASAI EAST ( VALIV )( CANDIDATES FROM BORIVALI-VIRAR CAN APPLY

R/M & P/M Dispensing, Reconciliation, Calculation mfg. of Injectable plantWashing Area Monitoring, ONLINE BMR, Logbook, formats, SOP, must have working in Autoclave, Vial, Ampoule, DHS M/c, DecodingManpower HandlingDocumentation & Formats, SOPRequired Candidate profileB. Sc. /B. Pharm/M.Sc/M.Pharm with injectable mfg - Responsible for Injectable Sterile, Aseptic mfg of pharma - formulation injectable plant, must have knowledge of Audit Documentation, Responsible for SOP.

Candidate should be FDA approved particularly in sterility and opening is at Tarapur MIDC Palghar .

Duties and Responsibilities: Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities and develop Data Management Plans that will deliver accurate, timely, consistent, and quality clinical trial data. Independently perform all activities related to data management per regulations and applicable standard operating procedures (SOPs). Primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects. Primary contact person for communication and discussion of topics related to data management timelines and deliverables, request for out of scope tasks, and first line contact for technical or procedural issues. Responsible for planning and implementing data management timelines and deliverables, for providing database and data management activities status reports, and contributes to the overall project planning, progress tracking and reporting. Design and review electronic Case Report Forms (eCRFs). Develop and review eCRF Completion Instructions. Generate and review annotated eCRFs. Develop and maintain data validation specifications. Fully involved in the clinical study database User Acceptance Testing (UAT), and ensure proper documentation thereof. Manage the process of database modifications (after go-live) due to protocol amendments or study needs. Regularly communicate and/or respond to data collection sites, third party service providers, and when appropriate sponsors; responding to queries in a timely manner,Qualifications: A minimum of 5 years of clinical data management related experience in either a CRO, pharmaceutical, biotech, or device company. In-depth understanding of database structures and database programming. In depth knowledge of CDISC SDTM/CDASH standards. In-depth knowledge of clinical trial processes and experience in ICH, GCP, and GCDMP (SCDM