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: Assistant Manager

Location: Bangalore, Karnataka, India

Department: Analytical Research and Development

Job Description:

Job Purpose: 

Responsible for the preparation of GMP documents in PD ARD GMP labs.

Key Responsibilities:

  • Preparation and review of procedures such as SOPs, IOPs, GAM.
  • Preparation and review of specifications for Raw materials, intermediates, and final products.
  • Preparation and review of validation protocols / Method reports.
  • Co-ordination for approval of all the procedures / Protocols and reports by the respective department.
  • Periodic updations of all procedures (Once every two years or as and when required) as per the system requirements.
  • Co-ordinate for the training of new recruits till she/he completes departmental training.
  • Initiation of change control, deviation, and CAPA.

  • Involving in the investigation of Deviation and the ensuing investigation is performed as per the procedure.
  • Involvement in providing compliance for audit observation along with Quality Assurance Department.
  • Exposure to QMS systems using the software such as ‘TrackWise’, ‘EDMS’, SAP and ‘LMS’.
  • Responsible for oversight of qualification and calibration of instruments.
  • Checking data integrity & reliability in the quality control as per 21CFR 11
  • Implementing and ensuring compliance to Quality control activities as per cGMP regulations, regulatory requirements
  • Stock maintenance of adequate glassware, chemicals, instruments, analytical columns, reference standard, and volumetric standards.

Qualification: M.Sc/B.Pharma/M.Pharma

Experience: 5-6 Years

Salary: Negotiable

Contact Details:

careers@syngeneintl.com

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