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Executive - QC Bioanalytical

0.00 to 3.00 Years   Chennai   28 Jun, 2021
Sygene
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaIT Operations / EDP / MIS
EmploymentTypeFull-time

Job Description

Designation: Executive Quality Control (Bioanalytical)Job Location: BangaloreDepartment: Clinical Development About 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: This role involves to support Quality Control activities in Bioanalytical Research Laboratory.Key Responsibilities:

  • To do data check (QC) for method development, validation and study sample analysis.
  • To check bioanalytical reports, concentration data, PK calculation worksheet.
  • To check necessary documents and records and make it ready for the audits (Sponsor/Regulatory/Accreditation Bodies).
  • To check the study-based process data and reports.
  • To prepare calibration schedule and co-ordinate for preventive maintenance schedule with the Engineering and Maintenance department.
  • To verify daily calibrations.
Educational Qualification: B. PharmTechnical/functional Skills: Should be aware of Bioanalytical Sample processing techniques. Basic knowledge on Mass spectrometer and HPLC. Should have attended GLP training once in a year. Knowledge on Food & Drug Administration (FDA) Method validation Guideline. Knowledge on EMEA Method Validation Guideline. Knowledge on ANVISA Method Validation GuidelineExperience: 0-3 years of experience in bioanalytical laboratory / Quality Control - bioanalyticalBehavioral Skills:Excellent and effective communication. Strong interpersonal skill to work in team and co coordinating with team. Time management skills.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 :
legislative relationstime managementequal employment opportunitymethod validationcontinuous improvement facilitationquality controlconsumer goodspreventive maintenancemethod developmentanimal health

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