I’m #hiring for Assistant Manager – Development Quality Assurance
at Syngene International Limited. DM for more details.
Designation: Assistant Manager
Job Location: Bangalore
Department: Development Quality Assurance
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.
- Assurance of laboratory compliance in line to internal standards and procedures in formulation and analytical development laboratory.
- Other responsibilities as assigned by reporting manager.
- 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 Lab notebooks.
- Review of regulatory submission documents if any.
- QMS review and approval in development functions.
- Assurance of quality in line with internal standards in formulation and analytical development laboratory.
Educational Qualification: M. Pharmacy / M. Sc
- Understanding of analytical lab compliance
- Knowledge of ICH guidelines
- Review of validation reports and development reports.
Experience: 6-9 years