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HPU QC executive role

0.00 to 3.00 Years   Chennai   28 Jun, 2021
Sygene
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Designation: Executive - Clinical Quality ControlJob Location: BangaloreDepartment:Human Pharmacology UnitAbout SyngeneIncorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.Job Purpose: Study and System related activity monitoring and documents reviewing process with respect to SOPs and regulatory guidelines as per Clinical trial study requirements.Key Responsibilities:

  • Perform QC checks of draft protocol, draft CRF, draft ICF and other study related requirements.
  • Observing the pre-check-in, check-in, pre-dose, dosing, post-dose activity as per protocol, SOP/IOPs regulatory guidelines as required.
  • 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.
  • Issue True copy of verified calibration / validation reports for display in their respective areas.
  • Co-ordinating with sponsor and monitors representatives during their visit for monitoring the study activity and assisting them with the documentation activity related to study procedure.
  • Checking draft SOP/IOPs as and when required.
  • Provide Line clearance, Line Opening and Line Cleaning for dispensing labels in pharmacy.
  • Archival of all study files.
  • Provide the response to sponsor/QA observation noted during their data review or visit to facility in coordination with HPU staff. Checking log books on weekly and month wise and maintaining track on calibration of equipments used in HPU.
  • Prepare and Present trend analysis to HPU team once in six months or as and when needed as per HOD instructions.
  • To carry out any other responsibility as and when assigned by the Head-Human Pharmacology Unit / Head of Syngene Clinical Development Team
Educational Qualification: B.Pharm, B.Sc, M.Pharm, M.ScTechnical/functional Skills: Knowledge on MS office, Clinical Trials, and good verbal communication.Experience: 0 - 3 YearsBehavioral Skills: Flexible, Quick learner, Adaptable, efficient in work and focused.Equal Opportunity Employer:It is the policy of Syngene 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 accommodations for qualified individuals with disabilities.,

Keyskills :
ms officehplctrend analysisequal employment opportunityinspectioncalibrationbaggage handling systemsdocumentationclinical trialsconsumer goodscontinuous improvement facilitationanimal healthisovalidation reports

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