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 - Analytical Development - Early Phase GMP
Job Purpose : This role involves in the analysis of Drug Substance/ Drug Product.
Key Responsibilities :
• Responsible for performing the physicochemical and instrumental analysis and investigations of samples (Drug substance, Drug Product, Intermediate, Excipient & Inactive) received at Early phase GMP (Analytical Department).
• Preparation of protocols, ODS and Annexure as per client requirement.
• Responsible for handling stability for multiple Client projects.
• Preparing stability summary reports and review of final documents.
• Actively participate in Client Audits and regulatory Audits.
• Ensure to follow cGMP and GDP.
• Deliver analytical results within the established windows and as per applicable guidelines.
• Responsible for performing Validation activities and method transfers for multiple Client projects.
• Preparing the Calculation excel sheets, certificate of Analysis for standards and impurities and Reports for Analytical Method Validation and Analytical Method Transfer.
• Responsible for Performing Qualification and Calibration of assigned Instrument’s and Equipment’s.
• Preparation of Instrument URS, DQ and IOP.
• Preparing the Standard Operating Procedure.
• Responsible for timely intimation/ investigation of any events, deviations to the Dept. Head, QA function and supporting the related investigations to the clients and its effective timely closure.
• Responsible for Timely deliverables of projects.
• Compliance & implementation of quality systems.
• Ensure optimal utilization of Work hours & prioritization of activities to meet departmental commitments.
• Flexibility to work in any project/team as per the requirement.
• Responsible for the activities assigned within the team.
• Escalation of issues / non conformity with applicable procedures/policies.
• 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.
• Should have Quality Control background.
• Should have knowledge on Analytical Techniques.
• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking-listening-writing skills, attention to details, proactive self-starter
• 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 be strong in Data Integrity.
• Should able to work in team and flexible for working in shifts
• Should be a focused employee.
Experience : 4-9 years
Qualification : M.Sc., M. Pharm, B.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Analytical Development
End Date : 10th October, 2020
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