Syngene Analytical Development Sr Executive Job - Apply Online

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.

Technical/Functional Skills:

Should have Quality Control background.

Should have knowledge on Analytical Techniques.

Experience: 4 – 9 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.

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.
  • 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.
See Also
Govt CDSCO Chemist Recruitment 2020 - Applications Invited

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