Syngene M Pharma Sr Executive Vacancy 2021 – Apply Online
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.
Job Purpose: To oversee method transfer, validation activities related to elemental assay and trace analysis, characterization of elemental impurities in trace and assay levels
Job Title: Senior Executive 1 (36881)
Educational Qualification:Â M. Pharm / M. Sc
Technical/Functional Skills:
• 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 pharmacopeias 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
Experience:
• 1-5 years of relevant experience in Quality Control department/Analytical Development Lab
Behavioral Skills:
• 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
Key Responsibilities:
• Planning of day-to-day activities and reviewing of documents.
• To execute stability analysis, validations, and method transfer 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 the 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 a 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
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