Assistant Manager – DISCOVERY & DEVELOPMENT QA (55084)
Requisition ID 55084 – Posted 10/26/2023 – India
Designation: Assistant Manager
Job Location: Bengaluru, India
Department: Discovery and Development QA
The Company
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb, and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development, and manufacturing facilities, Syngene works with biotech companies pursuing leading-edge science as well as multinationals including GSK and Merck KGaA.
The Role
- Overall responsible for Quality management system monitoring in Discovery Chemistry and other laboratory.
- Other responsibilities as assigned by the reporting manager.
Key Result Areas
Role-specific:
- Review and approval of laboratory Change control, deviations, investigations, and CAPA in Track wise.
- Tracking CCF, deviation, and incident closure status on weekly basis to achieve quality KPIs.
- Review and approval of SOP, IOP, OCP, and EOP.
- Handling customer projects and ensuring that the documents are reviewed and approved.
- Perform self-inspection of BUs as per schedule.
- Review of Audit trials of application software instruments and electronic lab notebook (eLN).
- Review and approval of Instrument qualification and scheduled calibration documents.
- Coordinating with the laboratory personnel in the handling of customer queries.
- Issuance of workbooks and logbooks.
- Review of regulatory submission documents, if any.
- Ensuring training compliance in line with training procedures and role-based curricula.
- Ensure lab compliance with respect to the laid down quality systems.
- Review and approve analytical documents comprising chromatographic data files, Lab Notebooks, and eLN.
- Review and approval of computerized system validation documents.
- Review and approval of Instrument qualification and scheduled calibration documents.
- Coordinating with the laboratory personnel in the handling of customer queries.
- Approval of validation/qualification documents as required.
- Other responsibilities as assigned by the reporting manager.
Education and Experience
Education: Master’s degree in pharmacy / Science/Biotechnology
Industry Experience: 08-10 years of relevant experience
Other competencies required for the role
Team player, Result-oriented, and focused.
Keywords: Assistant Manager, Discovery & Development QA, Requisition ID 55084, Job Location Bengaluru, Department Discovery and Development QA, Syngene International, Pharmaceutical, Biotechnology, Nutrition, Animal Health, Consumer Goods, Specialty Chemical, Scientists, Research, Development, Manufacturing, Biotech, GSK, Merck KGaA
