Job Title: Assistant Manager - Quality Management System (Analytical Assurance)
Experience in Analyticaal QA is must to this role.
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 8 to 10 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:
· 8 to 10 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
