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. 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.
Post : Assistant Manager - ARD
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 in every two years or as and when required) as per the system requirements.
• Co-ordinate for training of new recruits till she / he completes departmental training.
• Initiation of change control, deviation and CAPA.
• Involving in investigation of Deviation and ensuring investigation is performed as per 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.
Candidate Profile
• MSc /B. Pharm/M.Pharm
• Knowledge on Analytical instrument like HPLC, GC, etc
• Knowledge on Computer system validation (CSV) and Quality management system (QMS).
Additional Information
Experience : 5-6 years
Qualification : M.Sc, B.Pharm, M.Pharm
Location : Bangalore
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 30th August, 2020
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