Job for Executive in Quality Control Department at Syngene International Ltd

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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. 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.

Post : Executive (11341)

Job Description
Position Summary

• Responsible for preparation of documents such as SOPs, IOPs, EOPs etc. Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc.
• Responsible to perform the method transfer ananlysis and verification activity with documentation for the samples of in-process/finished product.
• Responsible for uploading and assigning SOP / EOP / IOP in LMS.
• Responsible to involve and participate during the preparation and general laboratory readiness for the internal / external / client audits.
• Responsible to complete all planned Quality & Compliance trainings as and when required by the department / Section head.
• To prepare the complete list of materials (CLM) required for various projects.
• Responsible to initiate and inform immediately to department HOD/designee, if there are any laboratory incidents, deviations, change controls and out of specification results were observed.
• Responsible to conduct any job assigned by the superior.
• Responsible for the training coordinator activity which includes providing of questionnaire, submitting the GTR to archival QA, preparation of JD, training matrix, training binder, review of training files and assigning training in LMS.
• Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples. Responsible for thr preparation of stability study related documents like, stability study protocols, observation data sheet, analysis report, stability summary and trend sheets.
• Responsible for the execution of stability samples charging  for stability study.

Candidate Profile
• Masters in life sciences (Biochemistry or biotechnology)
• Good Knowledge in protein chemistry.
• Good knowledge in execution of bioassay and binding ELISA analysis for Biologics of drug substances / finished product.
• Knowledge on analytical methods of proteins.
• UV spectrophotometer, pH meter, analytical weighing balance, Osometer, HPLC,  Plater readers, UPLS and CE instruments.
• Writing SOP's. Knowledge on LIMS.
• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking-listening-writing skills, attention to details, proactive self-starter.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should able to work in team and flexible for working in shifts.
• Should be a focused employee.

Additional Information
Experience : 1 -3 years
Qualification : M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Control-Biologics
End Date : 10th July, 2020

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