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Urgent! Sr. Executive - Quality Management System (Analytical Assurance) Job Opening In Ankleshwar – Now Hiring Zentiva Group, a.s.

Sr. Executive Quality Management System (Analytical Assurance)



Job description

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 6–8 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

  • Required Skill Profession

    Operations Specialties Managers



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