HomeProductionSr Executive | Quality Assurance - Biologics | Syngene International | Bangalore

Sr Executive | Quality Assurance – 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 Assurance

Location: Bangalore, Karnataka, India

Job Description:

Job Purpose:

This role involves in Analytical Quality Assurance activities pertaining to Quality Control Biologics (AQA activities of QC Biologics).

Key Responsibilities:

  • Review, approval of RM/PM/Consumable reports, and release in SAP.
  • Coordination in preparation and review of the QA SOPs in-line with current pharmaceutical guidelines.
  • Responding to queries providing support to customer/regulatory on analytical related documents/requests as per the customer/regulatory requirement.
  • Issuance of Analytical documents and document-related Raw Materials/Packing Materials/Consumables.
  • Review of analytical test records, Analytical testing records, Analytical Method Validation, Analytical method transfer, protocol, and report as per written procedures

  • Review of stability summary and stability reports generated by QC as per written procedures.
  • Handling and being part of the investigations related to deviations, Laboratory incidents, Out of calibrations, Out of specifications, CAPA, and Out of trend.
  • Handling & management of deviations, Laboratory incidents coordinating in identifying the root cause investigations with CAPA identification.
  • Handling, review, evaluation of change control, verification, and implementation of the Corrective and preventive action.
  • Review of specifications and STPs for RM/PM/IP/FP of QC Biologics.
  • Review of all laboratory analytical standard protocol, Reports & COAs.
  • Review of Instrument operating procedures, IQ/OQ/PQ/DQ of all instruments of QC.
  • To ensure the implementation of all EHSS norms to create a safe working environment.
  • Training of employees on various aspects like good documentation practices and Good Laboratory Practices.
  • 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:

  • Should be good in Quality Control instrumentation.
  • Should have knowledge in Analytical testing records, Analytical Method validation, Analytical method transfer

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

Qualification: M.Sc

Experience: 3-6 Years

Salary: Negotiable

Contact Details:

careers@syngeneintl.com

OR

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