QC Analyst

1 month ago

Bengaluru, Karnataka, India Syngene Full time

Job Title: QC Analyst

About Syngene:

Incorporated in 1993, Syngene International Ltd. is a global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries. Our innovative culture is driven by the passion of our team of scientists who work with clients worldwide to solve scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation.

Job Purpose:

The QC Analyst will be responsible for ensuring compliance with GMP, GDP, and GLP procedures, identifying the cause of non-compliance, and implementing improvement ideas to reduce nonconformance and increase productivity.

Key Responsibilities:

  • Ensure compliance with GMP, GDP, and GLP procedures and identify the cause of non-compliance.
  • Ensure compliance with Data integrity policy and identify the cause of non-compliance.
  • Ensure compliance with SOPs and approved instructions and identify the cause of non-compliance.
  • Perform self-inspection and ensure manufacturing operations are maintained in an all-time audit-ready (ATAR) state.
  • Ensure the archival of documents and third-party archival activity within SLA and ensure compliance from the respective department.
  • Review of Quality agreement as applicable. Maintain the list of Quality agreements.
  • Review of Client Questionnaire and ensure the confidentiality of documents.
  • Review of investigation, Categorize the Deviation and provide inputs in the identification of root cause.
  • Review change control. Approval of extension if change control unable to close within the specified timeline.
  • Initiation of investigation, risk assessment, and provide inputs in the identification of root cause and to propose the CAPA for identified CAPA.
  • Perform analysis by different analytical techniques like HPLC/GC/UV/IR/KF etc.
  • Have hands-on experience on analysis thru LIMS.
  • Investigation, provide inputs in the identification of root cause and to propose CAPA.
  • Ensure preparation and review of specification within SLA and ensure compliance.
  • Perform pharmacopeial/Regulatory Assessment/surveillance on introduction/revision of new/revised monograph and general chapters/guidelines.
  • Ensure the execution of process validation and cleaning validation activities.
  • Ensure CSV-related documents and ensure compliance from the concerned person/section.
  • Ensure the archival of documents and third-party archival activity within SLA and ensure compliance from the respective department.
  • Check consignment documents like COA, MSDS, GRN, TRF, FTRF etc and monitor sampling of Raw materials, packing materials, In-process, Validation, Finished products, water sampling, and miscellaneous materials as applicable and certify the accuracy, adequacy, and timeliness of the activity performed by analysts.
  • Handling of LMS, LIMS, ELN, TrackWise, and EDMS Softwares for routine activities as applicable.
  • Ensure the availability of optimum resources and operate the department within the specified budget. Support the Department Head in preparing the annual budget.
  • Communicate promptly and effectively with the clients and CFT members.
  • Ensure training completion before the startup of assigned activities.
  • Responsible for taking any other job allocated by the Head QC/Group Leader/Section Head.

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