HomeProductionExecutive - Quality Control (Common) | Syngene International | Bengaluru

Executive – Quality Control (Common) | Syngene International | Bengaluru

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Incorporated 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.

         

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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.

Position: Executive – Quality Control (Common)

Location: Bangalore, Karnataka, India

Job Description:

  • 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 the internal, client, and regulatory audits.
  • Compliance with quality systems in the 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.

Technical/Functional Skills:

  • 2.5 to 3 years of working experience in Stability and Quality control.
  • The candidate should have experience in the analysis of drug substances and drug products.
  • Good analytical skill and shall perform analysis right the 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 an added advantage.
  • Good understanding of GMP, GDP, and data integrity principles.
  • Quick learner and early change adaptor.
  • Experience in regulatory audits is a must.

Behavioral Skills:

  • Effective time Management.
  • Reading Comprehension

     

  • Communicating effectively: verbally and writing

     

  • Team player.

Qualification: M.Sc Analytical/Organic Chemistry, M.Pharma

Experience: 2.5 to 3 years of working experience in Stability and Quality control. (Drug substances and drug products)

Salary: Negotiable

Contact Details:

careers@syngeneintl.com

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