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.
Designation: Assistant Manager – QC Biologics
Location: Bengaluru, Karnataka
- Responsible for product testing and release, analytical method validation, analytical method transfers, and method verification activity in Quality control biologics.
- Be conversant with analytical techniques such as HPLC, UV spectrophotometer, colorimetric analysis, Capillary zone electrophoresis; UPLC, ICE, etc.
- Managing timely analysis as per the work allocation daily.
- Assisting in the technical aspects of the change control, CAPA, and test methods reviews and revisions and assisting to resolve laboratory incidents, out of specification (OOS), out of trends and deviations.
- Responsible for the managing of all activities related to product support in Quality control biologics.
- Shall participate in investigations, audits, and inventory management, continuous improvement initiatives for all the projects.
- Review of daily/monthly laboratory monitoring, verification, calibration records of Equipment, and instruments.
- Responsible to prepare CAPEX and OPEX based on requirements.
- Implementation of LIMS product and stability modules in Quality Control Biologics.
- Shall initiate experiments as needed.
- Continuous improvement in the competency matrix.
- Responsible to complete all planned quality and compliance training as and when required by the Department Head.
Safety & Compliance:
- Possess the knowledge and exposure to the environment, health, and safety (EHS) practices.
- Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
- Attend training on environment, health, and safety (EHS) measures imparted company.
Desired Candidate Profile & Skills
- Well versed with HPLC, UPLC, Gas Chromatograph, CZE, ICE, Method Validation execution, Quality System
- Capable of Meeting timelines and Deadlines, Prioritizing work, Developing New Ideas and Creative Solutions
- Good Communication, Interpersonal, Analytical and Organizational skills
Qualification: M.Sc – Biotech/Biochem
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