HomeProductionSr Executive Quality Control - Biologics | Syngene International | Bangalore

Sr Executive Quality Control – Biologics | Syngene International | Bangalore

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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: Sr Executive – Quality Control – Biologics

Location: Bangalore, Karnataka, India

Job Description:

Job Purpose:

This role involves in planning and execution of Bioassay and binding ELISA analysis for Biologics of drug substances/ finished product.

Key Responsibilities: 

  • Responsible for the preparation of documents such as SOPs, IOPs, EOPs, etc.
  • Preparation of batch release documents like specifications, STPs with the observation datasheet, verification protocols, method transfer protocols, etc.
  • Responsible to perform the method transfer analysis and verification activity with the documentation for the samples of in-process/finished products.
  • 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 training as and when required by the department/section or asked by the HOD / 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 training 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 the preparation of stability study-related documents like stability study protocols, observation datasheets, analysis reports, stability summary, and trend sheets. Responsible for the execution of stability samples charging for the stability study. Assistance in the setup of the bioassay lab as per the direction of Supervisor/ Section Head.
  • Preparation of batch release documents like specifications, STPs with observation datasheet, verification protocols, method transfer protocols, etc.
  • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
  • Attend training on environment, health, and safety (EHS) measures imparted company.

Technical/Functional Skills:

  • Knowledge of Bioassay and Binding ELISA analysis for Biologics substances/ finished product.
  • Experience in method transfer analysis and verification activity with the documentation for the samples of in-process/ finished products.
  • Ample knowledge of LIMS.

Behavioral Skills:

  • 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 detail, 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 a team and flexible for working in shifts.
  • Should be a focused employee.

Qualification: M.Sc Chemistry/Biotechnology

Experience: 3-6 Years

Salary: Negotiable

Contact Details:

careers@syngeneintl.com

OR

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