SYNGENE Career Opportunities: Senior Executive M. Pharm / M. Sc Apply Now

SYNGENE Career Opportunities: Senior Executive M. Pharm / M. Sc Apply Now

About Syngene

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. 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:  To oversee method transfer, validation activities related to elemental assay and trace analysis, characterization of elemental impurities in trace and assay levels

Key Responsibilities:

  • Planning of day to day activities and reviewing of documents.
  • To execute stability analysis, validations and method transfers on Flame emission spectrometry (FES), Atomic Absorption Spectrophotometer (AAS), Inductively coupled plasma Optical Emission Spectroscopic (ICP-OES) and Inductively coupled plasma mass spectrometry (ICP-MS) techniques as on required within timeline.
  • Review of document generated on stability analysis, validations, method transfers and calibrations.
  • Execution of validation protocols and routine analysis.
  • Preparation of validation and stability protocols and reports.
  • Preparations of Standard Operating Procedures (SOPs), Emergency Operating Procedures (EOPs) and IOPs and provide training whenever required.
  • To prepare draft investigation report for the deviations, Incidents, Out of Control (OOC), and Out of Specification (OOS).
  • To ensure the entire instrument for intended use meets the 21 CFR part 11 compliance.
  • To oversee the quality aspects of stability operations and ensure the compliance for stability testing and Laboratory information management system LIMS
  • Attend training on environment, health, and safety (EHS) measures imparted company
  • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety

Educational Qualification:

  • M. Pharm / M. Sc

Technical/functional Skills:

  • Should have hands on experience on ICP-MS/ ICP-OES/ AAS and FES and other wet analysis instrumentation.
  • Should be familiar with cGMP and ICH guidelines.
  • Good knowledge on US/EU pharmacopoeias and its recent updates.
  • Should be through with stability operations.
  • Should have good hands on experience in execution of stability testing in line with ICH guidelines and strict adherence cGMP.
  • Exposure to USFDA audits & thorough knowledge in maintaining the prerequisites in the implementation of 21 CFR Part 11 compliance will be treated as an added advantage.
  • Attend training on environment, health, and safety (EHS) measures imparted company

Experience:

  • 1-5 years of relevant experience in Quality Control department/Analytical Development Lab

Behavioral Skills:

  • Good communication, technical report writing skills and E- Mail etiquette.
  • Good team player
  • Able to work follow instructions and perform the tasks under the supervision of the Team leader

TO APPLY CLICK HERE

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