Lead out of specification investigations and core Quality Management System activities in the pharmaceutical industry, focusing on analytical assurance.
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
Top Skills
Gc
Hplc
Ir
Polarimeter
Titroprocessor/Kf
Uv
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