Urgent Requirement For AQA-Executive To Senior Executive

Job Type: Full Time
Department: Quality Assurance Analytical QA
Experience: 2–8 Years
Qualification: M.Sc / B.Pharm / M.Pharm in Chemistry, Pharmaceutical Sciences, or related field
Location: MSNF-II Kothur

Job Summary

We are looking for a Team Member – Analytical QA to support analytical quality assurance activities, laboratory data review, investigations, documentation, and regulatory compliance. The role will be responsible for ensuring analytical testing and documentation comply with cGMP, GLP, Data Integrity, and applicable regulatory requirements.

Key Responsibilities

• Review analytical reports for raw materials, packing materials, in-process samples, finished products, and stability samples.
• Review protocols and reports for photostability, freeze–thaw, in-use, score evaluation, diluent compatibility, CCIT, and other analytical studies.
• Review analytical reports for purified water, cleaning samples, hold-time studies, process validation, dissolution, and comparative dissolution studies.
• Review analytical method validation and method transfer reports.
• Review SOPs, specifications, standard test procedures, and electronic laboratory records.
• Review pharmacopoeial change evaluations and vendor notification changes.
• Review analytical trend reports for raw materials, packing materials, in-process and finished products, and stability results.
• Identify Out-of-Trend (OOT) limits and review OOT investigation reports.
• Review laboratory instrument qualification, calibration, preventive maintenance, breakdown maintenance records, and logbooks.
• Review investigations related to deviations, incidents, OOS, OOT, complaints, dissolution/UOD investigations, and market complaints.
• Review risk assessments and quality-related documentation.
• Prepare and review responses to regulatory queries and audit observations related to analytical activities.
• Review Change Controls, Deviations, and CAPA within the Quality Management System.
• Request, review, approve, and retrieve documents through DMS, including SOPs, formats, and Good Testing Practices (GTP) documents.
• Support Regulatory Affairs with dossier submissions, query responses, and customer document submissions.
• Review electronic data records for accuracy, completeness, and compliance with data integrity requirements.
• Review LIMS masters and analytical data tracking.
• Submit analytical documents to Regulatory Affairs for dossier submission.
• Issue Finished Product CoAs and review batch release checklists.
• Review temperature monitoring records for stability chambers.
• Perform additional responsibilities assigned by the reporting manager/designee.

Required Skills & CompetenciesRole & responsibilities

Preferred candidate profile