Zentiva is a producer of high-quality affordable medicines serving patients in Europe and beyond. With a dedicated team of more than 4 700 people and a network of production sites - including flagship sites in Prague, Bucharest, and Ankleshwar - Zentiva strives to be the champion of branded and generic medicines in Europe to better support people’s daily healthcare needs. At Zentiva it is our aspiration that healthcare should be a right and not a privilege.
Post : Executive - Quality Management System (Analytical Assurance)
Job Description
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
Candidate Profile
• B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field.
• 3–8 years of experience in Analytical Assurance within the pharmaceutical industry
• 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
Additional Information
Experience : 3–8 years
Qualification : B.Pharm / M.Pharm / M.Sc
Location : Ankleshwar
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Management System (Analytical Assurance)
End Date : 30th October 2025
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