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 Educational qualifications :