HomeProductionQuality Assurance Executive | Syngene International | Bengaluru

Quality Assurance Executive | Syngene International | Bengaluru

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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.

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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.

Position: Quality Assurance Executive

Location: Bangalore, Karnataka, India

Job Description:

  • Responsible for IPQA activities like line clearance and continuous monitoring of shop floor.
  • Verify the SOP VS practice and identify the gaps for plant upkeep.
  • Responsible for preparation, review, and revision of QA SOPs using the Software EDMS.
  • Handling of Change control, Deviation, and CAPA Systems for small molecules of GMP function through Track wise.
  • Handling Document management System.
  • Review and approval of master and executed BMRs’, PDRs’.
  • To support during client audits, regulatory audits, vendor audits.
  • Review of risk assessments.

Key Responsibilities:

  • Responsible for IPQA activities like line clearance and continuous monitoring of shop floor.
  • Verify the SOP VS practice and identify the gaps for plant upkeep.
  • Responsible for preparation, review, and revision of QA SOPs using the Software EDMS.
  • Handling of Change control, Deviation, and CAPA Systems for small molecules of GMP function through Track wise.
  • Handling Document management System.
  • Review and approval of master and executed BMRs’, PDRs’.
  • To support during client audits, regulatory audits, vendor audits.
  • Review of risk assessments.

Technical/Functional Skills:

  • Hands-on Experience in Track wise and EDMS.

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 detail, 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 able to work in a team and flexible for working in shifts.
  • Should be a focused employee.

Qualification: M.Sc/M.Pharm with minimum 6 + years of working experience with Pharmaceutical / Life science.

Experience: 4-6 years

Salary: Negotiable

Contact Details:

careers@syngeneintl.com

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