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Executive - Quality Management System (Analytical Assurance)

Zentiva Group, a.s.ankleshwar, India

2 days ago

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 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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Quality Assurance • ankleshwar, India