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: Jr Executive – Quality Assurance

Location: Bangalore, Karnataka, India

Job Description:

Job Purpose:

This role involves inline clearance during the Batch change over and Product Change over and conducting cGMP inspections across the manufacturing plant and supporting area

Key Responsibilities:

  • Responsible for issuance of Batch Numbers, Batch Manufacturing Records, Packing and Dispatch records.
  • Review of Master, Executed Batch Manufacturing Records, Packing, and Dispatch records.
  • Approving the Masterbatch documents.
  • In-process Product Quality Monitoring.
  • Logging, Review, Evaluation, and Closure of Change Control, Deviation, Customer complaint, and CAPA raised.
  • Investigation of Deviation and Customer Complaint.
  • Review of calibration, qualification, and validation reports.

  • Filing and Maintenance of Quality Documents/Records.
  • Dispatch inspection and Clearance.
  • Monitoring of dispensing and other relevant warehouse activity.
  • Vendor qualification of raw materials, packing materials, consumables, contractors engaged in manufacturing, testing, and providing other relevant services pertaining to the cGMP manufacturing with respect to vendor questionnaire verification, vendor audit and compliance report verification for approval.
  • Approval of vendors by desktop and site audits (as required).
  • Inspection of Raw material (RM), packing material (PM), and manufacturing consumables for any damage/discrepancy possible during receipt, storage, dispensing and handling of these materials in Warehouse.
  • Review and approval of SOPs pertaining to the Formulation Unit, Warehouse, and Materials Management.
  • Support and review of Warehouse related qualification documents.

  • Co-ordination and participation during customer/third party cGMP audits, regulatory audits, and internal quality audits.
  • Handling of the SAP-related activities related to Batch number creation, Quality info record, MDG code approval for FG/SF, ECN generation, and Batch release.
  • Issuance of Format numbers, Logbooks, Operating Procedures.
  • Co-ordination and participation during Internal Audit and Review of Internal Audit Reports.
  • To ensure implementation and propagation of all EHSS norms so as to create a safe working environment.
  • Responsible for the monitoring and review of the Quality Management System, Documentation, and records of Formulation Development Center (FDC).
  • 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 current regulatory requirements.
  • Knowledge and experience in handling Quality Management System.
  • Should have worked in Oral Solid Dosage Forms.

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.Pharma

Experience: 6-9 Years

Salary: Negotiable

Contact Details:

careers@syngeneintl.com

OR

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