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Pharmaceutical Quality Expert

2 weeks ago


Bengaluru, Karnataka, India beBeeQuality Full time ₹ 18,15,000 - ₹ 25,10,000
Job Title: Quality Specialist

The quality specialist will ensure that the review of critical documents is completed in a timely and compliant manner as per industry standards and related guidelines.

Responsibilities include:

  • Review of documentation related to method development, validation protocols, reports, stability protocols, and reports.
  • Review of instrument and equipment qualification records.
  • Review of batch manufacturing records.
  • Liaising with global teams for arranging required documents and query responses.
  • Escalation of issues to supervisor, group leader, or manager.

Key requirements include:

  • 2-8 years of experience in QA, QC function in the pharmaceutical industry.
  • Master's Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences.
  • Basic knowledge on worldwide regulations.
  • Good English language skills, other language skills could be helpful.

Preferred qualifications include:

  • Hands-on experience on analytical method development, method validation for API and FP of different analytical methods.
  • Stability studies.
  • Hands-on experience on review of instrument, equipment qualification records.
  • Basic knowledge, hands-on experience of review of BMR.
  • Basic knowledge, hands-on experience on product quality reviews.