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Senior Executive Quality Control 1

2.00 to 7.00 Years   Bangalore, Chennai, Hyderabad, Kolkata   27 Aug, 2021
Sygene
Job LocationBangalore, Chennai, Hyderabad, Kolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

Designation: SeniorExecutive Quality Control CommonJob Location:BangaloreDepartment: Quality Control Common.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.

  • Responsible for performing the physicochemical and instrumental analysis and investigations (Drug substance, Drug Product, Intermediate and Excipient) for stability testing lab.
  • Responsible for performing analytical method validation and analytical method transfer.
  • Deliver results Right First Time and within the established windows.
  • Participation in internal, client and regulatory audits.
  • Compliance with quality systems in laboratory.
  • Ensure and comply with GMP, GDP, Data Integrity EHS policies laid down by the organization.
  • Flexibility to work in any project/team as per the requirement.
  • Preparation of documents like stability summary reports, stability protocols, SOP.
  • Responsible for audit readiness.
  • Performance of instrument calibration, qualification whenever required.
Key Responsibilities:
  • First pass analysis of stability samples i.e. drug substances and drug products.
  • Ontime escalation of laboratory issues.
  • Initiation of QMS records on time.
Educational Qualification:
  • M. Pharmacy or M.Sc. (Analytical Chemistry/Organic Chemistry)
Technical/functional Skills:
  • 2.5 to 3 years of working experience in Stability and Quality control.
  • Candidate should have experience in analysis of drug substance and drug products.
  • Good analytical skill and shall perform analysis right first time.
  • Hand on experience of HPLC, GC, KF coulometer, KF titrator, Dissolution tester and IR. (experience in PXRD, DSC, Particle size analysis, LCMS is preferred.
  • Experience in Chromeleon software, LIMS, Trackwise will be added advantage.
  • Good understanding of GMP, GDP and data integrity principles.
  • Quick learner and early change adaptor.
  • Experience in regulatory audits is must.
Experience: 3-6 years of working experience in Stability and Quality control. (Drug substances and drug products)Behavioral Skills:
  • Effective time Management.
  • Reading Comprehension
  • Communicating effectively: verbally and writing
  • Team player.
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 :
equal employment opportunityparticle size analysiscontinuous improvement facilitationquality controldocumentationhplccalibrationanalytical method validationright first timekf titrator

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