Syngene Analytical Development Sr Executive Job – Apply Online
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Job Title: Senior Executive – Analytical Development – Early Phase GMP (18505)
Job Location: Bangalore
Department: Analytical Development – Early Phase GMP
Educational Qualification: M.Sc., M. Pharm, B.Sc.
Should have Quality Control background.
Should have knowledge on Analytical Techniques.
Experience: 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 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.
This role involves in the analysis of Drug Substance/ Drug Product.
- 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.
- 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.
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