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Sr Executive – Quality Assurance – GMP (Chemical Development) | 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: Sr Executive – Quality Assurance – GMP (Chemical Development)

Location: Bangalore, Karnataka, India

Job Description:

  • Responsible for preparation, review, and revision of QA SOPs using the Software EDMS.
  • Handling of Change control, Deviation, and CAPA Systems for small molecules of GMP function through Track wise.
  • Handling Document management System.
  • Review and approval of master Specifications’, ODSs’.
  • To support during client audits, regulatory audits, vendor audits.

Key Responsibilities:

  • Responsible to ensure the Effective Review of Analytical and Cleaning Method validation, Process validation, Excel validations, Forced degradations – protocols and reports,
  • Responsible to ensure quality management systems are followed in the Laboratory.
  • Responsible for ensuring logbooks are issued which are required for usage in Laboratory.
  • Responsible to ensure certificates of analysis are Review and approved of Raw Material, Packing material, Primary reference standard/ Working standard, Intermediate & Finished product.
  • Review & approval of specifications for FFP/PM/RM/IP/FP/INT.
  • Responsible to ensure the release of raw material, packaging material, intermediate & finished product batches in LIMS/SAP.
  • Responsible to ensure review & approval of analytical calibrations report in LIMS.
  • Responsible to ensure Review & approval of working/Lab/impurity/GC standards/ thawing time of standards COA and reports.
  • Ensuring method transfer activity is followed as per the procedure.
  • Ensuring of conducting regular GMP rounds at Quality Control Laboratory.
  • Ensuring CAPA’s are initiated to avoid the occurrence and effectively implemented.
  • Issuance of the documents (annexures, ODS, Calibration sheets, log sheets, etc.,)
  • Responsible to ensure the documents related to Analytical-QC are reviewed and approved. Responding to queries providing support to customer/regulatory on analytical related documents/requests as per the customer/regulatory requirement.
  • Responsible for Quality control activities, Monitoring & controlling the stability programs, DI compliance, OOS & OOT investigation, day to day compliance of QC with specific Quality guidelines.
  • Well-versed with preparation, review, and approval of QC-related documentation.

Technical/Functional Skills:

  • Hands-on Experience in Track wise and EDMS.

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

Qualification: M.Sc/M.Pharm with minimum 6 + years of working experience with Pharmaceutical / Life science.

Experience: 6=8 years

Salary: Negotiable

Contact Details:

careers@syngeneintl.com

OR

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