DQA Senior Executive Job at Syngene International Ltd | M.Pharm, M.Sc apply

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 : Senior Executive- DQA

Job Description
Job Purpose:
• Assurance of laboratory compliance in line to internal standards and procedures in development laboratory.
• Other responsibilities as assigned by reporting manager.

Key Responsibilities
• Review and approval of laboratory Change control, incidents, investigations and CAPA in Track wise.
• Review and approval of SOP, IOP, OCP and EOP.
• Handling of customer projects and to ensure the development documents are reviewed and approved.
• Review of Audit trials of application software instruments.
• Review and approval of Instrument qualification and scheduled calibration documents.
• Coordinating with the laboratory personnel in handling of the customer queries.
• Issuance of Logbooks and workbooks.
• Review of regulatory submission documents if any.
• Perform anytime audit readiness checks as per defined frequency.

Candidate Profile
• Assurance of quality in line with internal standards in development laboratories.
• Understanding of analytical lab compliance
• Knowledge of ICH guidelines
• Review of method transfer reports and development reports.
• Team player
• Result oriented and focused

Additional Information
Experience : 3-5 Year
Qualification : M.Pharm, M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Development Quality Assurance
End Date : 30th November, 2021