Executive - Quality Management System (Analytical Assurance)

2 weeks ago

Ankleshwar, India Zentiva Group, a.s. Full time

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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