Assistant Manager – Analytical Development – Early Phase GMP

  Medical Writing

Job title: Assistant Manager – Analytical Development – Early Phase GMP

Company: Sygene

Job description: Designation: Assistant Manager

Job Location: Bangalore

Department: Analytical Development – Early Phase GMP

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.

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.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. ,

Other details

Expected salary:

Location: Kolkata, West Bengal

Job date: Tue, 04 Jan 2022 08:42:00 GMT

Apply for the job now!

LEAVE A COMMENT