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
Job Description
Key Responsibilities
• Planning of day to day activities and reviewing of documents.
• To execute stability analysis, validations and method transfers on Flame emission spectrometry (FES), Atomic Absorption Spectrophotometer (AAS), Inductively coupled plasma Optical Emission Spectroscopic (ICP-OES) and Inductively coupled plasma mass spectrometry (ICP-MS) techniques as on required within timeline.
• Review of document generated on stability analysis, validations, method transfers and calibrations.
• Execution of validation protocols and routine analysis.
• Preparation of validation and stability protocols and reports.
• Preparations of Standard Operating Procedures (SOPs), Emergency Operating Procedures (EOPs) and IOPs and provide training whenever required.
• To prepare draft investigation report for the deviations, Incidents, Out of Control (OOC), and Out of Specification (OOS).
• To ensure the entire instrument for intended use meets the 21 CFR part 11 compliance.
• To oversee the quality aspects of stability operations and ensure the compliance for stability testing and Laboratory information management system LIMS
• Attend training on environment, health, and safety (EHS) measures imparted company
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
Candidate Profile
• M. Pharm / M. Sc
• Should have hands on experience on ICP-MS/ ICP-OES/ AAS and FES and other wet analysis instrumentation.
• Should be familiar with cGMP and ICH guidelines.
• Good knowledge on US/EU pharmacopoeias and its recent updates.
• Should be through with stability operations.
• Should have good hands on experience in execution of stability testing in line with ICH guidelines and strict adherence cGMP.
• Exposure to USFDA audits & thorough knowledge in maintaining the prerequisites in the implementation of 21 CFR Part 11 compliance will be treated as an added advantage.
• Attend training on environment, health, and safety (EHS) measures imparted company
• 1-5 years of relevant experience in Quality Control department/Analytical Development Lab
• Good communication, technical report writing skills and E- Mail etiquette.
• Good team player
• Able to work follow instructions and perform the tasks under the supervision of the Team leader
Additional Information
Experience : 1-5 Year
Qualification : M.Pharm, M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Analytical
End Date : 10th November, 2021
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