15 Aug
|
Pfizer
|
Visakhapatnam
15 Aug
Pfizer
Visakhapatnam
Experience: Master’s degree in chemistry/ pharmacy with 8-10 years of experience in Analytical Method Transfer / Validation executions in Quality control Laboratory and Quality Review of sterile dosage manufacturing facility.
Core Competencies
Analytical Method Validation/Transfers/Verification
Change Management process
Risk assessments principles and tools
Qualification of lab equipment’s
Regulatory requirements & Compendial Changes
Stability Management
Technical Skills
Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography),GC,IC, ICP-MS techniques
Qualified in multiple analytical techniques(HPLC-with Empower, GC, IC, ICP-MS, Potentiometry, UV‑Vis, FTIR, Karl Fischer, AAS, XRF, NIR and pH meters)
Demonstrated technical skills in method validation and testing
Having Capability to understand the Compendial methods and Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards.
Interpretation of analytical systems generates data against the procedure requirements.
Having capability to assess the test method requirements against USP, EP, BP, and JP requirements for Current Product Introduction (NPI).
Review of document analytical method verification and method transfer activities.
Demonstrate knowledge of ICH Q9 (Quality Risk Management) and apply risk‑based principles for identifying, assessing, controlling, communicating, and reviewing quality risks throughout the product lifecycle.
Perform identification, assay, purity, and related analytical tests using validated methods.
Having Knowledge on assessment of Elemental Impurities, Nitrosamine impurities, Extractable & Leachable and its guideline requirements.
Knowledge in validation principles and practices related to the Process validation, cleaning validation, Analytical Method validation, Water system, HVAC system, Equipment & Utility Qualifications.
Knowledge of various Quality tools required for investigations
Technical Writing- Ab
📌 Associate Manager (Visakhapatnam)
🏢 Pfizer
📍 Visakhapatnam