Assistant Manager 1 - Quality Management System (Analytical Assurance) job opportunity at Zentiva.

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DateMore Than 30 Days Ago bot
Zentiva Assistant Manager 1 - Quality Management System (Analytical Assurance)
Experience: 12-years
Pattern: full-time
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loacation India / Ankleshwar, India
loacation India / Ankles..........India

Job Title:  Assistant Manager - 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 8 to 12 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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