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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: Assistant Manager
Location: Bangalore, Karnataka, India
Department: Analytical Research and Development
Job Description:
Job Purpose:Â
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:
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