Syngene International Ltd is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve 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.
Job Description :
• 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.
Candidate Profile
• M.Sc., M.Pharm, B.Sc.
• Should have Quality Control background.
• Should have knowledge on Analytical Techniques.
• 4 – 9 Years
• 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 priorotize 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.
Additional Information
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 : 25th April, 2022
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