Executive - Quality Management System (Analytical Assurance)

As an Executive/ Sr. Executive in Quality Management System (Analytical Assurance), your role will involve leading the Out of Specification investigations and managing core QMS activities related to QC. Your responsibilities will include: - Triggering out of specification investigations when test results fall outside predefined specifications. You will be required to design and conduct tests to confirm or eliminate suspected root causes. - Handling QMS documents such as Incidents & Deviations. - Evaluating change control & CAPA processes. - Reviewing analytical documents like worksheets, specifications, methods of analysis, stability protocols & summary reports, and logbooks from the Quality Control department. - Reviewing and approving stability protocols. 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, specifically in pharmaceutical manufacturing (formulations). What We're Looking For: - 6-8 years of Analytical Assurance experience in pharmaceutical manufacturing (formulations). - Ability to investigate issues, identify root causes, and propose effective solutions. - Expertise in analytical techniques such as HPLC, GC, UV, Polarimeter, Titroprocessor/KF, IR. - Strong understanding of CGMP, FDA, MHRA, and ICH guidelines.,