Job Description

JOB DESCRIPTION
Designation: Senior Analyst - Stability and EGMP
Job Location: Bangalore
Department: Early phase GMP
About Syngene
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 worldwide. 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 more than 4000- 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.
: Performing analytical method validations and related documentation, as well as analysis of RM, PM, Intermediates, API, and Finished products.
Key Responsibilities: * Performing Chromatographic and Non-chromatographic analysis for Drug substances, Drug products, Intermediates, Excipients, etc...).

• Conduct the analysis on qualified techniques per the approved specification/protocol/procedures, interpret the data from analytical instruments, report the results, and promptly submit the completed documents for review within the established window.
• Recording of analytical observations/findings, reporting of data and results in observation data sheets, forms, logbooks, LIMS, and ELN application software, and support in preparing stability summary reports and review of final documents.
• Responsible for timely intimation/investigation of any events or deviations to the Department Head, QA function, supporting the related investigations to the clients, and timely closure.
• Instrument calibration as per schedule, hot water flushing of HPLC, and general preventive checks for laboratory instruments.
• Perform validation activities and method transfers for multiple client projects.
• Actively participate in client and regulatory audits. Ensure to follow cGMP and GDP.
• Preparing the certificate of analysis for standards and impurities and Reports for Analytical Method Validation and Analytical Method Transfer.
• Support in performing Qualification and Calibration of assigned Instruments and Equipment.
• Create/prepare documents, master data, and static data in LIMS, ELN, and LMS software as applicable.
• Outsourcing of sample testing is based on requirements and updating in respective logbooks.
• Coordination with engineering & maintenance and external vendors for preventive maintenance and calibration activity.
• Support in preparation of instruments URS, DQ, and IOP.
• Supported preparing standard operating procedures and uploading data in LIMS and other relevant activities per departmental requirements.
• Use of required safety PPE while sampling, analyzing, and working in the Laboratory.
• Individuals working in the GMP environment are responsible for documenting/recording the activities contemporaneously and accurately as per good documentation practices.
• Ensure safety compliance as per Syngene policy and EHSS requirements.
• Taking any other jobs by the Head QC/Group Leader/Designee.

To ensure safety compliance as per Syngene policy and EHSS requirements.
Educational Qualification: M Sc / M Pharma (Analytical/General chemistry)
Technical/Functional Skills: * Should be well versed with the latest analytical techniques like HPLC/GC, KF/KFC, IR/UV, LC-MS, GC-MS, IC, ICP-OES/ICP-MS, DSC, TGA, etc...

• Being well-versed in the Chromeleon data management application and LIMS will be advantageous.

Experience: Foundational
Behavioral Skills:

• Should be an adaptive learner.
• Should demonstrate effective Communication skills.
• Organization and ability to balance work and Life.
• Should possess good Time Management abilities.

Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status about public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Skills Required