Consulting

Quality Engineer
Noida and Bangalore, India
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Date: 24th May 2021

Job Status: Full Time

Essential Duties & Responsibilities

  • The person would be responsible for supporting the upkeep of the QMS.
  • Support in making changes to the QMS and working with function heads to coordinate process creation, template creations and updates to existing processes/templates.
  • Support in rolling out Trainings with regard to Processes
  • Drive, Track and close Non-Conformances raised across delivery groups as an outcome to process audits.
  • Follow-ups on audit outcomes and support in necessary documentation and connecting with action owners to drive closures
  • Coordinate and participate in the external audits/assessments.
  • Be accountable for reviewing and supporting key CSV deliverables – URS, Validation Plan, Test Plan,
  • Traceability Matrix, Test Summary Report and Validation Summary Reports.
  • Reviewing of the Qualification scripts (IQ, OQ, PQ scripts, results and reports) deliverables for
    Software categories.

Minimum Requirements

  • Quick learner with positive attitude
  • Software engineering discipline
  • Knowledge of GxP, QA best practices and regulatory guidelines
  • Experienced in Documentation authoring and requirement analysis (min. 3 years)
  • Can interpret business requirements to technical/ application requirements and vis-a- versa
  • Experienced in Process engineering (desirable)
  • Experience with electronic document management system is a plus.
  • Well-organized and detailed oriented professional, with strong verbal and written communication skills.
  • Must be self- motivated with ability to handle, organize and prioritize multiple tasks and be able to perform under pressure to meet deadlines.
  • Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner. Additional Qualifications
    BE/B.Tech/MCA from recognized institute with good academic score.
  • Quality professional with 4 years of hands-on experience with document control process in bio
    pharmaceutical industry.