Hpu Qc Executive

JOB DESCRIPTIONJob Location Bangalore Department Human Pharmacology UnitAbout Syngene Syngene International Ltd BSE 539268 NSE SYNGENE ISIN INE398R01022 is an integrated research development and manufacturing services company serving the global pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical sectors Syngene s 4500 scientists offer both skills and the capacity to deliver great science robust data management and IP security and quality manufacturing at speed to improve time-to-market and lower the cost of innovation With a combination of dedicated research facilities for Amgen Baxter Bristol-Myers Squibb and Herbalife as well as 1 9 Mn sq ft of specialist discovery development and manufacturing facilities Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA Key responsibilities Perform QC checks of draft CRF and other study related documents Monitor the pre-check-in check-in pre-dose dosing post-dose study activities as per protocol SOP IOPs and regulatory guidelines Perform Periodic checks for essential documents filed in TMF or study related files at different stages such as before study activity starts during the study and after the completion of the study QC check for source documents transcribed data with CRF entries and other study related documentation Provide Line clearance Line Opening and Line Cleaning to the Lab technician for the generation of Labels pertaining to Vacutainers and RIA vials Provide Line clearance Line Opening and Line Clearance for dispensing labels in pharmacy Generate Quality Control Report for study activities and or supporting documents Verify the response to sponsor QA observation noted during their data review or visit to facility in coordination with HPU staff and Investigators Review of CSR and appendices Archival of all study files Verification of oceasoft and archival as per the sop SOP-GCP-HPU-0065 Review of qualification documents as and when required Prepare and present trend analysis report of observations to Head HPU and reporting managers once in a month or as and when needed as per Head HPU instructions Issue True copy of verified calibration validation reports for display in their respective areas Review SOP IOPs as and when required Perform Quality Control checks of HPU facility systems and issue QC report and coordinate with concerned departmental person Head of HPU in resolution of observation clarification pertaining to systems To carry out any other responsibility as and when assigned by the Head-Human Pharmacology Unit Head-Syngene Clinical Development Experience 1-4 yearsQualification B PharmaEqual Opportunity Employer It is the policy of Syngeane to provide equal employment opportunity EEO to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law In addition Syngene will provide reasonable accommodation for qualified individuals with disabilities