Sr. Executive - Quality Management System (Analytical Assurance)

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Qualifications And Experience

• Education: B.Pharm / M.Pharm / M.Sc in Chemistry, Biotechnology, or related field.
• Experience: Minimum 68 years of experience in Analytical Assurance within the pharmaceutical industry
  

Job Responsibilities & Accountabilities

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