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

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DatePosted 30+ Days Ago bot
Zentiva Assistant Manager- Quality Management System (Analytical Assurance)
Experience: 10-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) 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

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