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 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.
Job Purpose:
This role involves in the analysis of Drug Substance/ Drug Product.
Job Description:
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.
Technical/functional Skills:
Should have knowledge on Analytical Techniques.
Experience: 0 – 3 Years
Behavioral Skills:
- 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.