Senior Executive

Job Description: Analyst Analytical Method Validation & Transfer
Position: Sr Research Associate / Assistant research scientist
Qualification: Minimum M Pharm (Exp 6 to 10 years in TT activity)

• Job Purpose

The Analyst is responsible for executing hands-on laboratory work related to Analytical Method Validation (AMV), Method Verification, and Analytical Method Transfer (AMT) for Formulations, APIs, and Excipients. The candidate ensures all operations strictly comply with current ICH, USFDA, and EMA guidance, cGLP/cGMP regulations, and robust Data Integrity principles.

Core Roles & Responsibilities
1. Technical Execution (AMV & AMT)

• Hands-on Analysis: Perform complete laboratory testing for validation, verification, and transfer of methods utilizing HPLC, UPLC, GC, UV-Vis, and Dissolution apparatus.
• Validation Parameters: Execute experiments to evaluate analytical parameters including Specificity, Linearity, Accuracy, Precision (Repeatability & Intermediate), Robustness, LOD/LOQ, and Solution Stability according to ICH Q2(R2) guidelines.
• Method Transfer: Support and execute co-validation, comparative testing, and transfer protocols between sending (SU) and receiving units (RU) in accordance with FDA/EMA technology transfer mandates.

2. Documentation & Compliance

• Protocol & Report Writing: Draft and review method validation protocols, validation reports, method transfer protocols, and transfer reports under standard guidelines.
• STP Development: Prepare Standard Test Procedures (STPs), Validation STPs (VSTPs), specifications, and standard operating procedures (SOPs).
• ALCOA+ Data Integrity: Maintain concurrent, accurate, and traceable documentation in Laboratory Notebooks (LNBs) and electronic data systems, adhering strictly to USFDA Data Integrity standards.

3. Equipment, Standards & Logistics

• Calibration & Maintenance: Perform daily calibration and routine verification of key laboratory instrumentation (pH meters, balances, HPLC, GC). Coordinate with engineering teams for Preventive Maintenance (PM).
• Reference & Column Management: Manage working standards, reference standards, impurities, and HPLC/GC column lifecycles according to approved SOPs.
• Sample Integrity: Receive, track, store under appropriate stability conditions, and safely dispose of routine and stability samples after testing.

4. Quality Management Systems (QMS) & Audits

• Event Logging: Initiate and support investigations for laboratory incidents, deviations, and Out-of-Specification (OOS) / Out-of-Trend (OOT) results.
• Change Control: Handle and document required laboratory changes via the proper Change Control channels.
• Audit Readiness: Participate in self-inspections and ensure the laboratory remains in a constant state of compliance for external USFDA, EMA, and regulatory audits.

Key Competencies & Regulatory Compliance

• Regulatory Knowledge: Strong baseline understanding of ICH Q2(R2) (Validation), ICH Q14 (Analytical Procedure Development), FDA guidance on Analytical Procedures and Methods Validation, and WHO/EMA guidelines on Tech Transfer.
• Data Integrity Focus: Full awareness of 21 CFR Part 11 requirements regarding electronic records, audit trails, and data security.
• Confidentiality & Safety: Maintain absolute confidentiality regarding customer-related information and intellectual property while executing all work safely.