Executive - Quality Management System (Analytical Assurance)

4 days ago

Ankleshwar, Gujarat, India Zentiva Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Job Title: Executive/ Sr. Executive - Quality Management System (Analytical Assurance)

Department: Quality Management System

Reports to: Manager

Location: Ankleshwar

Position Type: Full-time

Qualifications and Experience:

  • Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field.
  • Experience: Minimum 3–8 years of experience in Analytical Assurance within the pharmaceutical industry

Job Responsibilities & Accountabilities:

We are looking for an experienced Analytical Assurance professional to join our team and lead the Out of specification investigation, along with core QMS activities pertaining to QC.

Key Responsibilities:

  • Trigger out of specification investigations upon detection of test results outside predefined specifications. Design and execute tests to confirm or rule out suspected root causes.
  • Handling QMS documents i.e., Incidents & Deviations
  • To evaluate change control & CAPA
  • To review analytical documents i.e. worksheet, specification, method of analysis, stability protocol & summary report and logbook etc. of Quality Control department.
  • To review & approve stability protocol

What We're Looking For:

  • 6-8 years of Analytical Assurance experience in pharmaceutical manufacturing (formulations)

  • Ability to investigate issues, understand root causes, and suggest effective solutions

  • Expertise in analytical techniques (e.g., HPLC, GC, UV, Polarimeter, Titroprocessor/KF, IR).

  • Strong understanding of CGMP, FDA, MHRA, and ICH guidelines

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