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.
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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.
Position: Sr Executive – Quality Control
Location: Bangalore, Karnataka
- Good experience in Quality Control with a reputed pharmaceutical company.
- Experience in sampling and chemical analysis of Raw Materials, packaging materials, in-process, cleaning samples, Intermediates, Finished Product Samples, and validation.
- Perform analysis as per the written procedures and recording the observations contemporaneously in the respective records.
- Knowledge of 21 FR part 11 compliance requirements, ICH, and FDA guidelines.
- Awareness about Data Integrity policies/procedures, lab safety, and personnel safety
- Experience in the handling of QMS (laboratory incidents, deviations, OOS, and OOT).
- Preparing the QC Specifications, protocols, and performing the calibration of the QC Instruments.
- Following Good Laboratory Practices while working in QC Laboratory.
- To maintain and clean responsibility allotted for the individual instruments.
- Reviewing of Change controls, Validation documents protocols, and reports.
- Use of required safety apparels while sampling, analysis, and working in the laboratory. Ensure safety compliance as per Company policy and EHSS requirements.
- Responsible to perform the analytical activities as per the approved Specification, MOAs, IOP, GP, or protocol wherever applicable and generation of raw data with respect to its correctness, authenticity, completeness, and other aspects of data integrity as per Data Integrity policy.
- Laboratory Instrument calibration as per the written procedure.
- Troubleshooting of instruments like HPLC, GC, water content of KFT, KFC, and Potentiometer.
- Responsible for training to new joiners and reviewing of training documents and qualification documents.
- Interaction with Production, R&D, QA, and other departments for the smooth functioning of the activities.
- Initiation of laboratory incident and deviation.
- Preparation of draft reports and calculation sheets.
- Disposal of sample for analysis after use.
- Taking any other job allocated by HOD or Section Head.
- Analysis of Intermediate finished product, and Working standard qualification as per the specification.
- Ensuring, verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP.s
- Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
- Ensure environment, health, and safety (EHS) measures are imparted via training and adhered to within the team.
- Familiar with Chromatography and Non-Chromatography analysis of Drug Substances and Drug Product.
- Well experienced in analytical techniques using scientific instruments like HPLC, GC, FTIR, UV, NMR, polarimeter, KF/ Auto titrator, ICP-MS, ICP-OES, coulometry, and conventional methods.
- Hands-on experience in LIMS (Labware), Chrome Leon as an added advantage.
- Should have good communication skill and should be a good team player.
- Ability to work successfully in a dynamic, ambiguous environment.
- Ability to meet tight deadlines and prioritize workloads.
- Ability to develop new ideas and creative solutions.
- Should able to work in a team and flexible for working in shifts.
- Should be a focused employee.
Qualification: M.Sc Chemistry/M.Pharma
Experience: 3-6 Years
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