Quality Assurance Personnel


Job title: Quality Assurance Personnel

Company: Syngene International Limited

Job description: Designation: Executive

Job Location: Bangalore

Department: Quality Assurance GLP

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:

  • To Ensure the compliance to Organization for Economic Co-Operation and Development (OECD) principles of Good Laboratory Practices (GLP), CFR Part 11.

Job Description:

Key Responsibilities:

  • Receipt and review of general documents/SOPs Study Plans and Study Reports.
  • Preparation and /or review of SOPs and other documents related to QAU.
  • Maintain copies of approved Study Plans, MOA and general documents.
  • Review of SOPs, Study plans.
  • Performing/scheduling study, facility and process-based inspections.
  • Perform audit of study raw data & study report.
  • Report the observations/findings of inspections to the respective auditee and management in a timely manner.
  • Review of computerized system documents with respect to OECD 17,21 CFR Part 11.
  • 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.
  • Prepare the data for quality meetings.

Educational Qualification: Master of Science in Microbiology / Biotechnology/Biochemistry/ M.Pharm

Technical/functional Skills:

  • Should be well versed with OECD GLP Principles
  • Should be aware of conducting inspections and audits

Experience: 1-3 Years Experience.

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 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: Bangalore, Karnataka

Job date: Wed, 05 Jan 2022 08:52:34 GMT

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